Advertisement

BMC Anesthesiology

, 18:194 | Cite as

Tramadol for the treatment of catheter-related bladder discomfort: a randomized controlled trial

  • Shuying Li
  • Liping Song
  • Yushan MaEmail author
  • Xuemei Lin
Open Access
Research article
Part of the following topical collections:
  1. Perioperative medicine and outcome

Abstract

Background

Intra-operative urinary catheterization frequently causes postoperative catheter related bladder discomfort (CRBD) during recovery. We conducted this study to evaluate the efficacy of tramadol, which with muscarinic receptor antagonist property, as a treatment for CRBD.

Methods

Ninety patients who underwent elective gynecological surgery and complained of CRBD in the (PACU) were randomized into three groups of 30 each. Group A received normal saline, group B 1 mg/kg tramadol, and group C 1.5 mg/kg tramadol. The medication was administered from the Murphy’s dropper with a slow drip, and the severity of CRBD (none, mild, moderate, and severe) and postoperative pain were assessed after 0, 0.5, 1, 2 and 6 h.

Results

The severity of CRBD was reduced in group C compared with that in groups A and B at 1 h, and in groups C and B compared with that in group A at 2 h. The incidence of CRBD was reduced in group C compared with that in groups A and B at 2 h, and in group C compared with that in group A at 6 h. The visual analog scale (VAS) was reduced in group C compared with that in groups A and B at all time intervals. No differences in adverse effects were observed.

Conclusions

Tramadol 1.5 mg/kg was more effective than tramadol 1 mg/kg in treating CRBD and reducing postoperative pain, without significant side effects.

Trial registration

ChiCTR1800016390. Registered on 30 May 2018.

Keywords

Catheter-related bladder discomfort VAS Tramadol Treatment 

Abbreviations

ANOVA

one-way analysis of variance

CRBD

catheter related bladder discomfort

PACU

post-anaesthesia care unit

VAS

visual analog scale

Background

Urinary catheterization is universally used during surgery, though it can cause discomfort postoperatively. The clinical manifestation of catheter-related bladder discomfort (CRBD) may be discomfort in the supra-pubic region, or be similar to an overactive bladder, which manifests as urinary urgency and urinary frequency with or without urge incontinence [1]. CRBD is so distressing that it can increase postoperative agitation and pain, reduce the satisfaction of hospital stay, extend hospital discharge time, and increase the workload of medical staff [2]. As the postoperative incidence of CRBD can be as high as 47–90%, it often requires clinical intervention [2, 3].

Involuntary contraction of the bladder mediated by muscarinic receptors is the main cause of CRBD. A variety of antimuscarinic agents, such as tolterodine, oxybutynin, gabapentin, pregablin, butylscopolamine, paracetamol, ketamine, and dexmedetomidine, have been used to prevent CRBD, with varying degrees of success [4, 5, 6, 7, 8, 9, 10, 11]. Nonetheless, even with medication, the incidence of CRBD is still as high as 32–69%; thus urgent treatment is necessary [6, 9, 12, 13].

There are very few studies on the treatment of CRBD. The therapeutic drugs studied thus far include ketamine, butylscopolamine and hyoscine [14, 15, 16, 17]. Tramadol is a centrally acting opioid analgesic that has an antimuscarinic effect. Tramadol pretreatment has been proven to be effective for decreasing the incidence and severity of CRBD [13]. Accordingly, the present study was designed to investigate the efficacy of different dosages of tramadol as urgent treatment for postoperative CRBD and hypotheses that tramadol 1.5 mg/kg was more effective than tramadol 1 mg/kg.

Methods

This prospective, randomized, controlled, double-blind study was approved by the China Ethics Committee of Registering Clinical Trials and registered in the Chinese Clinical Trial Registry. Written informed consent was abtained from all patients.

Ninety patients with ASA physical status I–II, who underwent elective gynecological operation with 16 French Foley’s catheters inserted and spontaneously complained of CRBD in the PACU were enrolled. Ages ranged from 18 to 60 years. Exclusion criteria included overactive bladder, bladder outflow obstruction, neurogenic bladder, chronic analgesic abuse, morbid obesity, severe hepatic or renal disease, and inability to communicate.

Patients who complained of CRBD (moderate or severe) were randomized into three groups of 30 each using a computer-generated randomized number. Group A received normal saline, group B received 1 mg/kg tramadol, and group C received 1.5 mg/kg tramadol. The medication was administered from Murphy’s dropper with a slow drip by a PACU nurse who was not involved in the subsequent observation. All patients were monitored by ECG, non-invasive blood pressure, and pulse oximetry. The severity of CRBD, postoperative pain, and adverse effects (nausea, vomiting, dizziness, headache, drowsiness) were then assessed at 0, 0.5, 1, 2 and 6 h by an anesthesiologist who was blinded to the treatment.

The severity of CRBD was recorded as follows: none, did not complain of any CRBD even upon asking; mild, revealed only upon questioning; moderate, reported without questioning but was not accompanied by any behavioral response; and severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even trying to pull out the urinary catheter [4, 5, 6, 7, 8, 9]. Postoperative pain was assessed by the visual analog scale (VAS) score, which varied from 0 to 10, where 0 incicated no pain and 10 the worst imaginable pain.

The sample size was estimated based on a previous study with power analysis α = 0.05 and β = 0.1 to detect differences in the proportion of CRBD in a range of 0.1 to 0.6 between three groups; 24 patients were needed in each group [17]. Considering a 20% dropout rate, 30 patients were ultimately included in each group. The severity of CRBD and adverse effects were analyzed by the chi-squared test. Demographic data were assessed by one-way analysis of variance (ANOVA); postoperative pain was considered the repeated variables and was examined by repeated-measures ANOVA. The data were analyzed using SPSS 17.0, and P < 0.05 was considered significant.

Results

A total of 90 patients were recruited in this study, and no patients withdrew. There were no significant differences among the three groups with regard to characteristics of patient, duration of surgery, and intra-operative sufentanil requirement (Table 1).
Table 1

Patients characteristics and clinical data

 

Group A

Group B

Group C

Number of patients (n)

30

30

30

Age (year)

35.9 ± 7.7

37.0 ± 8.2

36.6 ± 9.0

Weight (kg)

56.7 ± 5.2

55.3 ± 4.4

55.6 ± 5.2

Duration of surgery (min)

118.3 ± 32.8

122.0 ± 34.9

121.2 ± 35.8

Intra-operative sufentanil requirement (ug)

25.5 ± 7.4

26.0 ± 8.0

25.3 ± 8.1

Among the three groups, there was no significant difference in CRBD severity at the first assessment in the PACU and 0.5 h postoperatively. However, the mild severity of CRBD was reduced in group C compared with that in groups A (P = 0.002) and B (P = 0.046) at 1 h (P = 0.008 among the three groups). The incidence of CRBD was lower in group C compared with that in groups A (P = 0.024) and B (P = 0.01) at 2 h (P = 0.012 among the three groups). The severity of CRBD was reduced in groups C (P = 0.005) and B (P = 0.008) compared with that in group A at 2 h (P = 0.005 among the three groups). The incidence of CRBD was reduced in group C compared with that in group A (P = 0.005) at 6 h (P = 0.013 among the three groups) (Table 2). VAS was reduced in group C compared with that in groups A and B at all time intervals (Fig. 1). There was no difference in adverse effects among the three groups (Fig. 2).
Table 2

Incidence and severity of CRBD presented as numbers (n)

Time

T0

T1

T2

T3

T4

Group

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

Severity

 No

   

0

0

0

0

0

7

5

4

13*

16

23

26***

 Mild

   

0

0

6

6

10

14*

8**

18

13

12

7

4

 Moderate

26

25

22

26

27

24

22

20

9

17**

8

4

2

0

0

 Severe

4

5

8

4

3

0

2

0

0

0

0

0

0

0

0

*P < 0.05 for comparison between group C vs groups A and B. **P < 0.05 for comparison between group A vs groups B and C. ***P < 0.05 for comparison between group A vs group C. T0: 0 h, T1: 0.5 h, T2: 1 h, T3: 2 h, T4: 6 h postoperatively

Fig. 1

Postoperative pain among the three groups

Fig. 2

The adverse effects among the three groups

Discussion

The severity of CRBD and postoperative pain in patients treated with 1.5 mg/kg tramadol was significantly reduced compared with those given 1 mg/kg tramadol and normal saline. No difference in adverse effects among the three groups was found.

It is clinically common for patients to complain of CRBD when awakening from anesthesia postoperatively and CRBD is identified as a risk factor for postoperative emergence agitation [18]. Severe CRBD usually results in strong vocal response, with shaking of arms and legs; patients will even attempt to pull out the urinary catheter. CRBD can exacerbate postoperative pain and increase the workload of medical personnel. However, CRBD is frequently neglected and left untreated clinically. Management of CRBD is beneficial to improving patients’ comfort and reducing postoperative emergence agitation and pain.

The major two independent predictors of CRBD are male gender and the diameter of the catheter [2]. Operation type is also regarded as one of the risk factors for CRBD, with urological and lower abdominal (such as obstetric and gynecological) surgeries having a higher incidence of CRBD [2, 19]. To eliminate these interference factors, we only enrolled women who underwent elective gynecological operation with a 16F Foley urinary catheter inserted.

Bladder involuntary contraction is mediated by muscarinic receptors, which are stimulated by acetylcholine. The urinary bladder has different types of muscarinic receptors; the M3 receptor leads to direct contraction and the M2 receptor is associated with indirect contraction of the bladder [20, 21]. The major mechanism of CRBD occurs through the M2 and M3 receptors. Tramadol is a centrally acting, synthetic opioid analgesic routinely used to manage postoperative pain. The effects of tramadol include inhibition of noradrenaline (NA), serotonin (5HT) reuptake, and M1 and M3 receptors [22]. Tramadol has been reported to be effictive in preventing the incidence and severity of CRBD [13]. It has also been used as a rescue therapy for moderate or severe CRBD at different dosages, such as 1.5 mg/kg or 50–100 mg [11, 23, 24, 25]. The present study evaluated the dose-response effect of tramadol for the management of CRBD. The onset time of tramadol is within 10 min, and the peak effect time is approximately 30 min. Therefore, we observed patients at 0.5 h after the medicine was administered. However, we did not find out any difference among the three groups at o.5 h.

Although adverse effects of nausea and vomiting for tramadol are very common [13, 26], dose–response adverse effects were not observed in this study, and there was no significant difference in the incidence of adverse effects among the three groups. Because the medication was administered from Murphy’s dropper with a slow drip, and the drug concentration was diluted. This study also investigated the dose–response effect of tramadol on postoperative pain relief. The VAS was reduced in group C compared with that in groups A and B at all time intervals; thus 1.5 mg/kg tramadol was more effective than 1 mg/kg tramadol at relieving postoperative pain relief.

There are some limitations in this study. First, we did not evaluate the efficacy of tramadol for all types of surgeries and different surgeries might have different degrees of interference. Moreover, we only observed up to 6 h after the medicine was administred. Although there was no difference in the severity of CRBD among the three groups at 6 h, the half-life of tramadol is 6 h; thus a longer observation time may be necessary. In addition, all the patients enrolled in this study were women, and male gender might have some associated interference.

Conclusion

In conclusion, tramadol 1.5 mg/kg was more effective than tramadol 1 mg/kg in treating CRBD and reducing postoperative pain without significant side effects.

Notes

Acknowlegements

Not applicable.

Funding

No funding.

Availability of data and materials

The datasets are not publicly available, but available from the corresponding author on reasonable request.

Authors’ contributions

LSY: study design, data collection, data analysis and writing paper. SLP: data collection. MYS: study design, data analysis and manuscript revision. LXM: Study design and manuscript revision. All authors read and approved the final manuscript.

Ethics approval and consent to participate

Ethical approval was obtained from China Ethics Committee of Registering Clinical Trials (ChiECRCT-20,180,059), address: West China Hospital, Sichuan University, NO. 37, Guo Xue Xiang, Chengdu, Sichuan, China. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR1800016390, date of registration: 2018-5-30) prior to patient enrollment. Written informed consent was abtained from all patients.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

  1. 1.
    Andersson KE. The pharmacology of lower urinary tract smooth muscles and penile erectile tissues. Pharmacol Rev. 1993;45:253–308.Google Scholar
  2. 2.
    Bai Y, Wang X, Li X, et al. Management of catheter-related bladder discomfort in patients who underwent elective surgery. J Endourol. 2015;29:640–9.CrossRefGoogle Scholar
  3. 3.
    Binhas M, Motamed C, Hawajri N, Yiou R, Martly J. Predictors of catheter-related bladder discomfort in the postanaesthesia care unit. Ann Fr Anesth Reanim. 2011;30:122–5.CrossRefGoogle Scholar
  4. 4.
    Agarwal A, Raza M, Singhal V, et al. The efficacy of tolterodine for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Anesth Analg. 2005;101:1065–7.CrossRefGoogle Scholar
  5. 5.
    Tauzin-Fin P, Sesay M, Svartz L, Krol-Houdek MC, Maurette P. Sublingual oxybutynin reduces postoperative pain related to indwelling bladder catheter after radical retropubic prostatectomy. Br J Anaesth. 2007;99:572–5.CrossRefGoogle Scholar
  6. 6.
    Agarwal A, Dhiraaj S, Pawar S, Kapoor R, Gupta D, Singh P. An evaluation of the efficacy of gabapentin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebocontrolled, double-blind study. Anesth Analg. 2007;105:1454–7.CrossRefGoogle Scholar
  7. 7.
    Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. J Anesth. 2014;29:212–6.CrossRefGoogle Scholar
  8. 8.
    Nam K, Seo JH, Ryu JH, et al. Randomized, clinical trial on the preventive effects of butylscopolamine on early postoperative catheterrelated bladder discomfort. Surgery. 2015;157:396–401.CrossRefGoogle Scholar
  9. 9.
    Ergenoglu P, Akin S, Yalcin Cok O, et al. Effect of intraoperative paracetamol on catheter-related bladder discomfort: a prospective, randomized, double-blind study. Curr Ther Res Clin Exp. 2012;73:186–94.CrossRefGoogle Scholar
  10. 10.
    Shariat MR, Lajevardi M, Khajavi M, Najafi A, Shariat MG, Etezadi F. Effects of intra-operative ketamine administration on postoperative catheter-related bladder discomfort: a double-blind clinical trial. Pain Pract. 2014;14:146–50.CrossRefGoogle Scholar
  11. 11.
    Kim HC, Lee YH, Jeon YT, et al. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: a double-blind randomised study. Eur J Anaesthesiol. 2015;32:596–601.CrossRefGoogle Scholar
  12. 12.
    Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006;96:377–80.CrossRefGoogle Scholar
  13. 13.
    Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intraoperative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008;101:506–10.CrossRefGoogle Scholar
  14. 14.
    Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006;96:587–9.CrossRefGoogle Scholar
  15. 15.
    Ryu JH, Hwang JW, Lee JW, et al. Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2013;111:932–7.CrossRefGoogle Scholar
  16. 16.
    Salama AK. Comparison between ketamine and hyoscine for the management of postoperative catheter-related bladder discomfort: a randomized controlled double-blind study. J Anaesthesiol Clin Pharmacol. 2017;33:76–80.CrossRefGoogle Scholar
  17. 17.
    Safavi M, Honarmand A, Atari M, Chehrodi S, Amoushahi M. An evaluation of the efficacy of different doses of ketamine for treatment of catheter-related bladder discomfort in patients underwent urologic surgery: a prospective, randomized, placebo-controlled, double-blind study. Urol Ann. 2014;6:51–6.CrossRefGoogle Scholar
  18. 18.
    Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2000 patients. Can J Anaesth. 2010;57:843–8.CrossRefGoogle Scholar
  19. 19.
    Li C, Liu Z, Yang F. Predictors of catheter-related bladder discomfort after urological surgery. J Huazhong Univ Sci Technolog Med Sci. 2014;34:559–62.CrossRefGoogle Scholar
  20. 20.
    Chess-Williams R. Muscarinic receptors of the urinary bladder: detrusor, urothelial and prejunctional. Auton Autacoid Pharmacol. 2002;22:133–45.CrossRefGoogle Scholar
  21. 21.
    Yamanishi T, Chapple CR, Chess-Williams R. Which muscarinic receptor is important in the bladder? World J Urol. 2001;19:299–306.CrossRefGoogle Scholar
  22. 22.
    Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017;12:1281–91.CrossRefGoogle Scholar
  23. 23.
    Kim HC, Lim SM, Seo H, Park HP. Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study. J Anesth. 2015;29:831–5.CrossRefGoogle Scholar
  24. 24.
    Kim HC, Hong WP, Lim YJ, Park HP. The effect of sevoflurane versus desflurane on postoperative catheter-related bladder discomfort in patients undergoing transurethral excision of a bladder tumour: a randomized controlled trial. Can J Anaesth. 2016;63:596–602.CrossRefGoogle Scholar
  25. 25.
    Kim HC, Park HP, Lee J, Jeong MH, Lee KH. Sevoflurane vs. propofol in post-operative catheter-related bladder discomfort: a prospective randomized study. Acta Anaesthesiol Scand. 2017;61:773–80.CrossRefGoogle Scholar
  26. 26.
    Langley PC, Patkar AD, Boswell KA, Benson CJ, Schein JR. Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin. 2010;26:239–51.CrossRefGoogle Scholar

Copyright information

© The Author(s). 2018

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors and Affiliations

  1. 1.Department of Anesthesiology, Key Laboratory of Birth Defects and Related Diseases of Women and ChildrenWest China Second Hospital of Sichuan UniversityChengduChina

Personalised recommendations