Efficacy and Safety of Urethral Catheter with Continuous Infusion of Ropivacaine after Urologic Surgery: A Pilot Prospective Randomized Controlled Trial
<p>Urethral catheter before use (<b>A</b>) and during use (<b>B</b>).</p> "> Figure 2
<p>Preference and discomfort with analgesic-eluting urethral catheter use by group. (<b>A</b>) Preference (<span class="html-italic">p</span> = 0.658). (<b>B</b>) Discomfort (<span class="html-italic">p</span> = 0.558).</p> "> Figure 2 Cont.
<p>Preference and discomfort with analgesic-eluting urethral catheter use by group. (<b>A</b>) Preference (<span class="html-italic">p</span> = 0.658). (<b>B</b>) Discomfort (<span class="html-italic">p</span> = 0.558).</p> ">
Abstract
:1. Introduction
2. Patients and Methods
2.1. Patients and Design
2.2. Detailed Processes of Study
2.3. Study Endpoints
2.4. Sample Size Calculation
2.5. Randomization of Groups
2.6. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Kim, C.R.; Jang, E.B.; Hong, S.H.; Yoon, Y.E.; Huh, B.K.; Kim, S.N.; Kim, M.J.; Moon, H.S.; Choy, Y.B. Indwelling urinary catheter assembled with lidocaine-loaded polymeric strand for local sustained alleviation of bladder discomfort. Bioeng. Transl. Med. 2021, 6, e10218. [Google Scholar] [CrossRef] [PubMed]
- Bala, I.; Bharti, N.; Chaubey, V.K.; Mandal, A.K. Efficacy of gabapentin for prevention of postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor. Urology 2012, 79, 853–857. [Google Scholar] [CrossRef] [PubMed]
- Bai, Y.; Wang, X.; Li, X.; Pu, C.; Yuan, H.; Tang, Y.; Li, J.; Wei, Q.; Han, P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J. Endourol. 2015, 29, 640–649. [Google Scholar] [CrossRef] [PubMed]
- Chapple, C.; Steers, W.; Norton, P.; Millard, R.; Kralidis, G.; Glavind, K.; Abrams, P. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU Int. 2005, 95, 993–1001. [Google Scholar] [CrossRef] [PubMed]
- Li, S.; Li, P.; Wang, R.; Li, H. Different interventions for preventing postoperative catheter-related bladder discomfort: A systematic review and meta-analysis. Eur. J. Clin. Pharmacol. 2022, 78, 897–906. [Google Scholar] [CrossRef] [PubMed]
- Shim, J.W.; Cha, S.; Moon, H.W.; Moon, Y.E. Effects of Intraoperative Magnesium and Ketorolac on Catheter-Related Bladder Discomfort after Transurethral Bladder Tumor Resection: A Prospective Randomized Study. J. Clin. Med. 2022, 11, 6359. [Google Scholar] [CrossRef] [PubMed]
- Singh, A.; Kayina, C.A.; Naik, N.; Ganesh, V.; Kumar, S.; Pandey, V.K.; Bora, G.S.; Saini, K.; Soni, S.L.; Kaloria, N.; et al. Transurethral lidocaine (100 mg) bladder irrigation (TULI100) reduces the incidence of catheter related bladder discomfort in transurethral resection of bladder tumors: A randomized, double blind, controlled trial. Int. J. Urol. 2023, 30, 264–270. [Google Scholar] [CrossRef] [PubMed]
- Marchenko, I.V.; Trushina, D.B. Local Drug Delivery in Bladder Cancer: Advances of Nano/Micro/Macro-Scale Drug Delivery Systems. Pharmaceutics 2023, 15, 2724. [Google Scholar] [CrossRef] [PubMed]
- Lee, H.; Cima, M.J. An intravesical device for the sustained delivery of lidocaine to the bladder. J. Control. Release 2011, 149, 133–139. [Google Scholar] [CrossRef]
- Nickel, J.C.; Jain, P.; Shore, N.; Anderson, J.; Giesing, D.; Lee, H.; Kim, G.; Daniel, K.; White, S.; Larrivee-Elkins, C.; et al. Continuous intravesical lidocaine treatment for interstitial cystitis/bladder pain syndrome: Safety and efficacy of a new drug delivery device. Sci. Transl. Med. 2012, 4, 143ra100. [Google Scholar] [CrossRef]
- Imai, H.; Seino, Y.; Baba, H. Efficacy of a novel urinary catheter for men with a local anesthetic injection port for catheter-related bladder discomfort: A randomized controlled study. J. Anesth. 2020, 34, 688–693. [Google Scholar] [CrossRef] [PubMed]
- Barry, M.J.; Fowler, F.J., Jr.; O’Leary, M.P.; Bruskewitz, R.C.; Holtgrewe, H.L.; Mebust, W.K.; Cockett, A.T. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J. Urol. 1992, 148, 1549–1557, discussion 1564. [Google Scholar] [CrossRef] [PubMed]
- Jeong, S.J.; Homma, Y.; Oh, S.J. Korean version of the overactive bladder symptom score questionnaire: Translation and linguistic validation. Int. Neurourol. J. 2011, 15, 135–142. [Google Scholar] [CrossRef] [PubMed]
- Park, J.; Shin, D.W.; You, C.; Chung, K.J.; Han, D.H.; Joshi, H.B.; Park, H.K. Cross-cultural application of the Korean version of Ureteral Stent Symptoms Questionnaire. J. Endourol. 2012, 26, 1518–1522. [Google Scholar] [CrossRef] [PubMed]
- Kang, H. Sample size determination and power analysis using the G*Power software. J. Educ. Eval. Health Prof. 2021, 18, 17. [Google Scholar] [CrossRef]
- Zhang, T.; Li, H.; Lin, C.; An, R.; Lin, W.; Tan, H.; Cao, L. Effects of an intraoperative intravenous Bolus Dose of Dexmedetomidine on postoperative catheter-related bladder discomfort in male patients undergoing transurethral resection of bladder tumors: A randomized, double-blind, controlled trial. Eur. J. Clin. Pharmacol. 2024, 80, 465–474. [Google Scholar] [CrossRef]
- In, C.B.; Lee, S.J.; Sung, T.Y.; Cho, C.K.; Jee, Y.S. Effects of Chlorpheniramine Maleate on Catheter-Related Bladder Discomfort in Patients Undergoing Ureteroscopic Stone Removal: A Randomized Double-Blind Study. Int. J. Med. Sci. 2021, 18, 1075–1081. [Google Scholar] [CrossRef]
- Kim, D.H.; Park, J.Y.; Yu, J.; Lee, S.A.; Park, S.; Hwang, J.H.; Koh, G.H.; Kim, Y.K. Intravenous Lidocaine for the Prevention of Postoperative Catheter-Related Bladder Discomfort in Male Patients Undergoing Transurethral Resection of Bladder Tumors: A Randomized, Double-Blind, Controlled Trial. Anesth. Analg. 2020, 131, 220–227. [Google Scholar] [CrossRef]
- Binhas, M.; Motamed, C.; Hawajri, N.; Yiou, R.; Marty, J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann. Fr. Anesth. Reanim. 2011, 30, 122–125. [Google Scholar] [CrossRef]
- Li, C.; Liu, Z.; Yang, F. Predictors of catheter-related bladder discomfort after urological surgery. J. Huazhong Univ. Sci. Technol. Med. Sci. 2014, 34, 559–562. [Google Scholar] [CrossRef]
- Mitobe, Y.; Yoshioka, T.; Baba, Y.; Yamaguchi, Y.; Nakagawa, K.; Itou, T.; Kurahashi, K. Predictors of Catheter-Related Bladder Discomfort after Surgery: A Literature Review. J. Clin. Med. Res. 2023, 15, 208–215. [Google Scholar] [CrossRef] [PubMed]
- Liang, S.; Pang, Z.; Zhou, N.; Liu, Z.; Guo, Q.; Huang, J.; Zou, W. Development and validation of a prediction model for catheter-related bladder discomfort: A prospective observational study. Br. J. Anaesth. 2022, 129, e147–e149. [Google Scholar] [CrossRef] [PubMed]
- Graf, B.M. The cardiotoxicity of local anesthetics: The place of ropivacaine. Curr. Top. Med. Chem. 2001, 1, 207–214. [Google Scholar] [CrossRef] [PubMed]
- Atanassoff, P.G.; Ocampo, C.A.; Bande, M.C.; Hartmannsgruber, M.W.; Halaszynski, T.M. Ropivacaine 0.2% and lidocaine 0.5% for intravenous regional anesthesia in outpatient surgery. Anesthesiology 2001, 95, 627–631. [Google Scholar] [CrossRef]
- Veerman, H.; Houwink, A.P.I.; Schutte, P.F.E.; Nieuwenhuijzen, J.A.; Roeleveld, T.A.; Wit, E.; Mazel, J.W.; van der Sluis, T.M.; Vis, A.N.; van Leeuwen, P.J.; et al. Intraoperative Strategies to Reduce Catheter-Related Bladder Discomfort in the Early Postoperative Period after Robot-Assisted Radical Prostatectomy. J. Urol. 2021, 205, 1671–1680. [Google Scholar] [CrossRef]
Control Arm | Study Arm 1 | Study Arm 2 | p Value | |
---|---|---|---|---|
(n = 20) | (n = 20) | (n = 20) | ||
Age (year) | 60.6 ± 9.5 | 54.8 ± 10.0 | 56.9 ± 13.5 | 0.509 |
ASA score 1–2 | 16 (80.0%) | 16 (80.0%) | 16 (90.0%) | 1.000 |
3 | 4 (20.0%) | 4 (20.0%) | 4 (20.0%) | |
Body mass index | 23.8 ± 4.8 | 25.5 ± 3.9 | 25.4 ± 4.3 | 0.616 |
Diabetes mellitus | 2 (10.0%) | 4 (20.0%) | 4 (20.0%) | 0.787 |
Hypertension | 12 (60.0%) | 8 (40.0%) | 10 (50.0%) | 0.670 |
Previous catheter history | 10 (50.0%) | 6 (30.0%) | 8 (40.0%) | 0.659 |
Operation procedure | 0.627 | |||
Ureteroscopic stone surgery | 10 (50.0%) | 12 (60.0%) | 16 (80.0%) | |
Scrotal surgery | 4 (20.0%) | 4 (20.0%) | 0 (0.0%) | |
Renal surgery | 6 (30.0%) | 4 (20.0%) | 4 (20.0%) | |
Length of stay (day) | 2.6 ± 2.4 | 3.0 ± 2.9 | 1.6 ± 1.3 | 0.387 |
Length of postoperative catheterization (day) | 1.3 ± 0.7 | 1.3 ± 0.5 | 1.0 ± 0.0 | 0.287 |
Control Arm | Study Arm 1 | Study Arm 2 | p Value | |
---|---|---|---|---|
(n = 20) | (n = 20) | (n = 20) | ||
CRBD | 10 (50.0%) | 2 (10.0%) | 3 (15.0%) | 0.002 |
Bladder discomfort score (pre-catheterization) (VAS) | 0.4 ± 0.5 | 0.5 ± 0.7 | 0.5 ± 0.5 | 0.909 |
Bladder discomfort score (post catheterization) (VAS) | 2.1 ± 1.0 | 1.6 ± 1.2 | 0.9 ± 0.9 | 0.045 |
Complication rate (all Clavien–Dindo Gr 1) | 10 (50.0%) | 4 (20.0%) | 10 (50.0%) | 0.287 |
Peri-catheter leakage | 2 (10.0%) | 2 (10.0%) | 10 (50.0%) | 0.057 |
Acute urinary retention | 0 (0%) | 2 (10.0%) | 0 (0%) | 0.355 |
Urethral pain VAS score (pre-catheterization, Pre) | 0.4 ± 0.5 | 0.4 ± 0.5 | 0.5 ± 0.5 | 0.885 |
Urethral pain VAS score (post catheterization, Post) | 6.2 ± 2.2 | 1.5 ± 0.8 | 1.4 ± 1.0 | <0.001 |
Total IPSS score (Pre) | 9.0 ± 4.3 | 7.4 ± 6.2 | 9.2 ± 10.3 | 0.838 |
Total IPSS score (Post) | 9.1 ± 4.4 | 7.6 ± 5.9 | 10.9 ± 9.9 | 0.592 |
IPSS QoL score (Pre) | 3.2 ± 1.0 | 2.6 ± 1.2 | 2.7 ± 1.8 | 0.591 |
IPSS QoL score (Post) | 3.2 ± 1.0 | 2.7 ± 1.4 | 3.1 ± 1.6 | 0.692 |
Total OABSS score (Pre) | 4.2 ± 1.8 | 3.2 ± 2.8 | 3.2 ± 3.2 | 0.629 |
Total OABSS score (Post) | 4.4 ± 2.0 | 3.4 ± 3.0 | 3.5 ± 3.3 | 0.687 |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Kim, K.T.; Shim, M.; Huh, K.; Song, S.H.; Uhm, Y.J.; Son, I.T.; Chung, K.J.; Kwak, D.-K.; Choi, Y.H.; Kim, H. Efficacy and Safety of Urethral Catheter with Continuous Infusion of Ropivacaine after Urologic Surgery: A Pilot Prospective Randomized Controlled Trial. J. Pers. Med. 2024, 14, 835. https://doi.org/10.3390/jpm14080835
Kim KT, Shim M, Huh K, Song SH, Uhm YJ, Son IT, Chung KJ, Kwak D-K, Choi YH, Kim H. Efficacy and Safety of Urethral Catheter with Continuous Infusion of Ropivacaine after Urologic Surgery: A Pilot Prospective Randomized Controlled Trial. Journal of Personalized Medicine. 2024; 14(8):835. https://doi.org/10.3390/jpm14080835
Chicago/Turabian StyleKim, Kwang Taek, Myungsun Shim, Kookjin Huh, Sang Hoon Song, Young Jun Uhm, Il Tae Son, Kyung Jin Chung, Dae-Kyung Kwak, Yi Hwa Choi, and Hwanik Kim. 2024. "Efficacy and Safety of Urethral Catheter with Continuous Infusion of Ropivacaine after Urologic Surgery: A Pilot Prospective Randomized Controlled Trial" Journal of Personalized Medicine 14, no. 8: 835. https://doi.org/10.3390/jpm14080835