Efficacy and Safety of Urethral Catheter with Continuous Infusion of Ropivacaine after Urologic Surgery: A Pilot Prospective Randomized Controlled Trial
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
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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 |
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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