Effect of continuous infusion in alleviating pain during male urethral catheterization | BMC Anesthesiology | Full Text

Jul 01, 2025

BMC Anesthesiology volume 24, Article number: 457 (2024) Cite this article

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The aim of this study was to explore whether continuous infusion causing lubrication can effectively alleviate pain during male urethral catheterization.

This prospective, multicenter, double-blinded study included 190 male patients scheduled for urethral catheterization. Patients were randomly allocated into four groups: Group A: the catheter was lubricated with paraffin; Group B: the catheter was lubricated with compound lidocaine gel; Group C: the pump continuously infusing with sterilized water; Group D: the pump continuously infusing with 2% lidocaine. The primary outcome was the visual analogue scale (VAS) scores. Statistical analysis system (SAS) (version 9.4) was used to perform all the statistical analyses. Significance for all results was set at P < 0.05.

The VAS of Group D was the lowest (18.90 ± 11.44), followed by the Group C (33.00 ± 11.07), and the VAS of Group A was the highest (53.98 ± 14.76). There were significant differences in VAS in Group D compared to Group A(P < 0.0001), Group B(P < 0.0001) and Group C (P < 0.0001), Group C compared to Group A (P < 0.0001) and Group B(P < 0.0001), Group B compared to Group A (P < 0.0001), indicating that patients treated with lidocaine infusion (Group D) experienced significantly less pain than did those in the other three groups.

Continuous infusion with sterilized water during catheterization is an efficient method for lubricating the urethral mucosa; furthermore, infusion with 2% lidocaine provides better analgesia as well as lubrication.

The study protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2300070866) (https://www.chictr.org.cn/showproj.html?proj=194591) on Apr. 25th, 2023.

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Catheterization is widely used in hospitals, particularly, when the majority of patients are awake and require preoperative indwelling catheterization [1]. Insertion of a catheter into the bladder through the urethra may result in significant pain and discomfort [2], this procedure has been rated by patients in the Emergency Department as one of the four most painful procedures [2,3,4]. Moreover, the male urethra has a longer, more complicated course than the female urethra, making it more susceptible to injury during catheterization [1], leading to significantly more severe pain, ranging from urethral mucosa irritation over urethral lesions, to strictures and false passages [5]. Thus, it is critical to minimize the discomfort and pain during catheterization.

Lubricants with anesthetics were first applied in urological procedures after the 19th century, after which several lubricant anesthetics were developed [6]. However, controversies have been raised on the effectiveness of lubricants with or without anesthetics during catheterization, several studies [2, 7,8,9] found that there is no significant difference in pain relief between these two methods, and that the use of anesthetics is not risk-free, lidocaine lubricant can lead to side effects such as allergies, elevated blood pressure and heart rate; rarely, it can lead to serious systemic complications such as neurotoxicity and cardiac arrest [8, 10], indicating that a more stable and effective method of catheterization is needed.

Study [11] has shown that in patients with difficulty urinary catheterization, such as severe prostatic hyperplasia, sterile water injection with a syringe at the site of resistance can effectively dilate the urethra and facilitate the forward delivery of the catheter. We also found that continuous infusion with sterilized water or 2% lidocaine during catheterization has the effects of lubrication as well as analgesia. In this study, we aimed to compare the effects of commonly used paraffin, lidocaine gel, continuous infusion with sterilized water, or 2% lidocaine during catheterization to determine how to minimize procedural pain and enhance lubrication in male urethral catheterization in the clinic.

This was a prospective, multicenter, double-blinded RCT conducted at 6 hospitals between April 28th 2023 and July 31st 2023. The study protocol was registered prior to patient enrollment at the Chinese Clinical Trial Registry and was approved by the Clinical Research Ethics Committee of The Second Xiangya Hospital, Central South University. The written informed consent was obtained from all subjects participating in the trial. The trial was strictly designed in accordance with the CONSORT statement, and all the patients signed informed consent before the procedure.

Block randomization was used in this clinical trial. Two hundred male patients aged 18 to 70 years were randomized at a 1:1:1:1 ratio to one of four treatment groups. Patients in each center were randomized and allocated to one of four groups at a ratio of 1:1:1:1 by using computer-generated random codes, which were generated by using the Proc Plan procedure in Statistical analysis system (SAS) (version 9.4), setting specific numbers as block length and block size. The exclusion criteria were as follows: (1) had an altered mental state; (2) had paresthesia or anesthesia; (3) had impaired visual acuity preventing completion visual analogue scale (VAS) scores; (4) refused to use treatments; (5) were allergic to lidocaine or paraffin, or were using other medications that interact with the above drugs; (6) had a severe chronic disease or vital organ dysfunction; (7) had urinary tract infection; (8) had severe structural abnormalities of the urethra, or severe prostate hyperplasia; and (9) analgesics used in the last 24 h.

The study was set up into four groups: Group A: the catheter was lubricated with paraffin; Group B: the catheter was lubricated with compound lidocaine gel(10 ml:10 g, H13021217, Handan Kangye Pharmaceutical Co., LTD); Group C: the pump (Micro-infusion pump) continuously infusing (with speed 600 ml/h) with sterilized water through the front end of the catheter; Group D: the pump continuously infusing (with speed 600 ml/h) with 2% lidocaine (5 ml:0.1 g, H31021072, Hai Zhaohui Pharmaceutical Co., LTD) through the front end of the catheter. All the catheters were double-chamber 16-Fr Foley catheters, and the catheters used in group C and group D were not covered by any lubricant substance.

After obtaining written informed consent, a series of opaque consecutively numbered envelopes were opened to reveal the patient’s assignment. The envelopes contained experimental assignments, an independent nurse who was not involved in patient care will prepare the supplies according the envelope and the catheter outlet ends in the four groups were all installed and connected to the pumps without working before catheterization. Catheterization was performed by the same doctor at each center, and the duration of catheterization (from when the catheter entered the urethral meatus to the completion of catheterization) was controlled from approximately 30s to 90s. If resistance is encountered during the procedure, adjustments will be made until the catheter goes through. Patients who could not complete catheterization after multiple adjustments or whose procedure duration exceeded 120s were excluded from the study. In patients assigned to Group A or Group B, the pumps were off during the whole procedure; in patients assigned to Group C and Group D, the pumps were continuously infusing with sterilized water or lidocaine starting from the catheter entering the urethral meatus, until catheterization was completed. Immediately after catheterization, patients were asked to rate the pain of experienced during procedure by the same assessor. Assessors, nurses, and patients were blinded to the infusion methods throughout the study.

Patients’ characteristics such as age, weight, height, baseline blood pressure (BP), and baseline heart rate (HR) were collected before the procedure. Changes in BP and HR were recorded during catheterization. Immediately after catheterization, patients were asked to rate the pain associated with the procedure on a previously validated 100-mm visual analog scale (VAS) (primary outcome), which was marked “most painful” at the high end, and “no pain” at the other end.

SAS (version 9.4) was used to perform all the statistical analyses. We considered a between-group VAS minimum mean difference of 1.1 and a standard deviation of 0.798. To achieve a power of 90% at a threshold of 0.05, the calculated sample size was 50 patients in each group. Demographic and baseline characteristics are shown as the means ± standard deviations and the numbers(percentages) for categorical variables. Continuous data were analyzed using One-Way ANOVA (factors: the method of continuous infusion during urethral catheterization) and Turkey’s post-hoc test. Turkey post-ho was used for multiple comparisons. Categorical data were analyzed using the CMH test. Shapiro-Wilk test was used for normally distributed data. Levene’s test was used to measure the homogeneity of variance. Significance for all the results was set at P < 0.05.

A total of 200 male patients were enrolled, and each group was randomly assigned 50 patients. 10 patients (2 in Group A, 6 in Group C, and 2 in Group D) were excluded because of mistaken inclusion or their own request to withdraw from the study. Hence, 48 patients in Group A, 50 patients in Group B, 44 patients in Group C, and 48 patients in Group D were included in the analysis. (Fig. 1). The patients’ mean ages were 46.3 ± 10.6, 48.8 ± 10.5, 49.6 ± 11.6, and 50.3 ± 9.1 years in four groups. There were no significant differences among the groups concerning age, body height, body weight, baseline diastolic BP (DBP) / systolic BP (SBP) / mean arterial pressure (MAP), or baseline HR. The study groups did not differ in demographics or clinical characteristics (Table 1).

Study flow diagram. A total of 215 male patients were selected for screening, 200 were assessed for eligibility, and each group was randomly assigned 50 patients. 10 patients (2 in Group A, 6 in Group C, and 2 in Group D) were excluded because of mistaken inclusion or their own request to withdraw from the study. Hence, 48 patients in Group A, 50 patients in Group B, 44 patients in Group C, and 48 patients in Group D were included in the analysis. Changes in BP and HR were recorded during catheterization. Group A: The catheter was lubricated with paraffin; Group B: The catheter was lubricated with compound lidocaine gel; Group C: The pump continuously infusing with sterilized water without the catheter lubricated; Group D: The pump continuously infusing with 2% lidocaine without the catheter lubricated

The VAS of Group D was the lowest (18.90 ± 11.44), followed by Group C (33.00 ± 11.07), and the VAS of Group A was the highest (53.98 ± 14.76). Similarly, the proportion of patients with moderate or above pain (VAS ≥ 50) in Group D (2.1%)was the lowest, followed by Group C (2.3%), and Group A accounted for the largest proportion (60.4%) (Table 2). As seen in Suppl. Table 1 (The model has 3 degrees of freedom, the error has 186 degrees of freedom, F-value = 76.89, P < 0.0001), the results generated by this model are reliable. There were significant differences in Group D compared to Group A(P < 0.0001), Group B(P < 0.0001) and Group C (P < 0.0001), Group C compared to Group A (P < 0.0001) and Group B(P < 0.0001), Group B compared to Group A (P < 0.0001) (Table 3) in VAS. Indicating that patients treated with lidocaine infusion (Group D) experienced significantly less pain compared with the other three groups (Fig. 2; Table 3). During catheterization, the changes in BP and HR showed a decreasing trend from Group A to Group D, with the least changes occurring in Group D (ΔDBP − 0.15 ± 4.64, ΔSBP 1.04 ± 7.33, ΔMAP 0.25 ± 5.08, and ΔHR 3.90 ± 4.73) (Table 2, Suppl. Figure 1).

VAS of the four groups during catheterization. The VAS of Group D was the lowest (18.90 ± 11.44), followed by Group C (33.00 ± 11.07), and the VAS of Group A was the highest (53.98 ± 14.76). And there were significantly differences in Group D compared to Group A (P < 0.0001), Group B (P < 0.0001), and Group C (P < 0.0001) separately, indicating that patients treated with lidocaine infusion (Group D) experienced significantly less pain than did the other three groups. Group A: The catheter was lubricated with paraffin; Group B: The catheter was lubricated with compound lidocaine gel; Group C: The pump continuously infusing with sterilized water through the front end of the catheter; Group D: The pump continuously infusing with 2% lidocaine

Our study demonstrated that continuous infusion through the urethral meatus during catheterization could effectively lubricate the urethra, thus reducing pain. Furthermore, 2% lidocaine infusion via a pump could significantly relieve the pain.

Due to its low cost [12] and easy availability [13], paraffin is the most commonly used lubricant for urethral catheterization in clinics; however, the patients in the control group experienced the most pain during catheterization. We consider the practice of lubricating the catheter in paraffin is not sufficient because it may be wiped off at the entrance to the urethra [14]; thus, the lubrication effects are decreased. The urethral lumen is very sensitive to the passage of any instrument [15], and the friction caused by catheters can directly lead to damage of the mucous membrane, thus further aggravating the pain.

Topical anesthetics have been used in urology since the 19th century [2], and topical lidocaine applied to the genital mucosa was found to be an effective analgesic, with a rapid onset of action, approximately 40 s to 4 min [15, 16], lasting approximately 10 to 45 min [6, 17]. Lidocaine is a tertiary amide, and its mechanism of action is to block sodium-gated channels which are necessary for propagating action potentials as well as stabilizing neuronal membranes [17] to emit pain signals [13], studies [16] have also indicated that it functions in repairing mucosal lacerations. Our study demonstrated that using catheters lubricated with lidocaine gel caused a lower VAS and less pain during catheterization than did lubricating with paraffin. However, the VAS was still greater in these two pump infusion groups (Group C and Group D). One of the reasons might be that the gel was wiped off by the urethral entrance, which lessens the anesthetic effect. The second reason might be that catheterization started before the gel was fully absorbed. Furthermore, controversies have raised on the effects of using lidocaine and paraffin during catheterization recently, studies [2, 7,8,9] found there were no benefit of lidocaine over plain lubricant in decreasing pain perception, indicating that a more stable and effective method of catheterization is needed.

According to our study, continuous infusion with sterilized water through the front end of the catheter during catheterization results in much less pain than the other two methods. Harkin et al. [11]. reported that in patients with difficult urinary catheterization, such as severe prostatic hyperplasia, sterile water injection via a syringe at the site of resistance can effectively facilitate catheter forwarding. We speculated that continuous infusion would create a water film on the surface of the urethral mucosa, which could dilate the urethra, as well as form a protective film, thus reducing the friction between the urethra and the catheter, and alleviating the damage to the mucous membrane, to play a better lubrication effect. Because lidocaine can effectively block the conduction of action potentials [13], blocking the afferent nerve of the urethral sphincter, thus relieving the spasm of the urethral sphincter caused by pain and tension, and reducing urethral mucosa irritation from urethral lesions, to strictures or false passages [5], we further used 2% lidocaine infusion during catheterization, and found that it most significantly decreased the VAS of the patients. In addition, only one patient in this group experienced moderate or greater pain. Due to the pressure of the neck of bladder, most of the lidocaine pumped through the urethra flows out with the continuous advancement of the catheter while forming a water film, additionally, liquid residue and related adverse events avoided. It is indicated that continuous infusion of 2% lidocaine has a stable and effective analgesic effect, and also provides continuous lubrication to the mucosa.

Safety issues have always been a concern with topical anesthetics. The adverse events related to lidocaine gel administration include allergy [18], ocular discomfort, dysuria [19], elevated blood pressure, accelerated heart rate, paresthesia, cardiac arrest, and even shock [1, 8]. The constant use of anesthetics may also provoke alterations in the central nervous system, such as restlessness, mild headache, lethargy, convulsions, paresthesia, unconsciousness, and respiratory arrest [6]. Excessive amounts, short intervals between doses, and long duration of urethral exposure can result in high plasma levels of lidocaine or its metabolites and serious adverse effects [20]. In addition, mucosal integrity may play an important role. In the case of urethral injuries, absorption across the damaged mucosa is rapid, and a high peak systemic concentration from the absence of the hepatic first-pass effect is reached [20], thus leading to lidocaine toxicity [16]. Although the concentration of lidocaine used during standard catheterization usually does not reach toxic concentrations [16, 20], the lesions caused during the procedure may further promote the absorption of the drugs. Direct injection of lidocaine gel in the urethra before catheterization is a common procedure in some clinics; however, it may cause additional unnecessary pain induced by sphincteric distention or the damage by the tip of the syringe that is inserted into the urethra in order to allow intraurethral gel injection [21, 22]. Continuous infusion during catheterization could protect mucosal membranes from damage, thus reducing the occurrence of the above side effects to some extent, and there were no relevant adverse events occurred in our study. Furthermore, the overall cardiovascular response from Groups A to Group D showed a decreasing trend, especially the changes in Group D was the least, indicating that continuous infusion with lidocaine during catheterization not only reduces pain, but also alleviates the cardiovascular response caused by stimulation. Therefore, continuous infusion liquid improves lubrication and relieves pain during catheterization, especially for patients with contraindications to lidocaine, and provides a new low-pain catheterization option.

Although continuous infusion of 2% lidocaine during catheterization can significantly alleviate pain compared to that in the other three groups, some patients still felt mild pain, thus, we considered several possible explanations. First, patients may be emotionally distressed, especially those who previously experienced pain, and might be more sensitive and more anxious during the study. Second, the irritation caused by cold exposure cannot be alleviated with an anesthetic [23]. Third, through the anatomically tight areas of the urethra that are rich in afferent nerves such as the external sphincter, the catheter can provoke irritation and pain [22]. Fourth, the chemical composition of an anesthetic might also cause pain [20, 22]. Fifth, the catheterization procedure may have caused some tissue damage.

The main limitation of our study was the lack of absolute blinding. There was a slight opacity difference between the study gels, however, this difference was difficult to visualize when they were placed on the surface of the catheters, and both Group A and Group B had markedly greater VAS scores than did the other groups. The liquid leakage in the continuous infusion groups may indicate grouping, but it was difficult for the patients to detect which group they were in, since lidocaine and sterile water are both transparent and odorless liquids. Second, catheterization was performed using unified 16-Fr Foley catheters, and we did not compare the different sizes of Foley catheters. Third, a larger population is needed to further validate our study. Finally, patients stayed in the postanesthesia care unit (PACU) for various periods of time after surgery, therefore, we did not evaluate the duration of the beneficial effect.

Our study demonstrated that continuous infusion with sterilized water during catheterization is an efficient method for lubricating the urethral mucosa. Furthermore, infusion with 2% lidocaine provides better effect of analgesia as well as lubrication.

Data is provided within the manuscript and its supplementary information files.

Central South University

Visual analogue scale

Blood pressure

Heart rate

Systolic blood pressure

Diastolic blood pressure

Mean arterial pressure

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This work was supported by The Science and Technology Innovation Program of Hunan Province [2023RC3084, Xin Qi]; Outstanding Youth Fund Program, Natural Science Foundation of Hunan Province [2023JJ20085, Xin Qi]; National Nature Science Foundation of China [82301264, Xin Qi], and National Key Research and Development Program of China [2018YFC2001902, Junmei Xu]. All of the above fundings were contributed in the study design, the collection, analysis and interpretation of data.

Lijun Cao and Xin Qi contributed equally to this work.

Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China

Lijun Cao, Dan Liu, Jia Qi, Junmei Xu & Yulong Cui

Department of Ophthalmology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China

Xin Qi

Department of Anesthesia, Guilin Hospital of the Second Xiangya Hospital, Central South University, Guilin, Guangxi, 541000, China

Lijun Cao, Jia Qi & Yulong Cui

Anesthesiology Department, Shenzhen Center, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Guangdong, 518116, China

Dan Liu

Department of Anesthesiology, Zhuzhou Hospital Affiliated to Xiangya School of Medicine, Central South University, Zhuzhou, Hunan, 412000, China

Xincheng Mao & Liu Luo

Department of Anesthesiology, The First People’s Hospital of Chenzhou, Chenzhou, Hunan, 423000, China

Mengjiang Liu

Department of Anesthesiology, Wenzhou People’s Hospital, Wenzhou, Zhejiang, 325000, China

Xinyi Wen

Department of Otolaryngology, the Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550001, China

Chunhong Cui

The Second Xiangya Hospital, Central South University, No.139, Renmin Middle Road, Changsha, Hunan, 410011, China

Yulong Cui

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LJC: Conceptualization, data curation, formal analysis, resources, writing - original draft; XQ: Conceptualization, funding acquisition, investigation, methodology, writing - original draft, project administration, project administration, validation; DL: Data curation, formal analysis, visualization; XCM: Data curation, formal analysis, visualization; LL: Data curation, formal analysis, visualization; MJL: Data curation, formal analysis, visualization; XYW: Data curation, formal analysis, visualization; CHC: Data curation, formal analysis, visualization; JQ: Data curation, formal analysis, visualization; JMX: Funding acquisition, investigation, validation; YLC: Conceptualization, data curation, investigation, methodology, project administration, resources, software, supervision, validation, visualization, formal analysis, writing - review & editing.All authors read and approved the final manuscript.

Correspondence to Yulong Cui.

The study was approved by the Clinical Research Ethics Committee of the Second Xiangya Hospital, Central South University. The trial was strictly designed in accordance with the CONSORT statement and Helsinki Declaration, and all the patients have signed the informed consent to participate the study before the procedure.

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The authors declare no competing interests.

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Below is the link to the electronic supplementary material.

Supplementary Material 1: Comparisons of ▵BP and ▵HR among the four groups. During catheterization, the changes in BP and HR showed a decreasing trend from Group A to Group D, with the least changes occurring in Group D (▵DBP − 0.15 ± 4.64, ▵SBP 1.04± 7.33, ▵MAP 0.25 ± 5.08, and ▵HR 3.90 ± 4.73). Group A: The catheter was lubricated with paraffin; Group B: The catheter was lubricated with compound lidocaine gel; Group C: The pump continuously infusing with sterilized water through the front end of the catheter; Group D: The pump continuously infusing with 2% lidocaine

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Cao, L., Qi, X., Liu, D. et al. Effect of continuous infusion in alleviating pain during male urethral catheterization. BMC Anesthesiol 24, 457 (2024). https://doi.org/10.1186/s12871-024-02848-4

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Received: 05 September 2024

Accepted: 04 December 2024

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DOI: https://doi.org/10.1186/s12871-024-02848-4

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