drugset / Trial / NCT04587505
Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.
RandomizedParallel-groupDouble-blindTreatment
Summary
Postoperative quality of recovery (QoR) could be related to anesthesia and postoperative analgesia. This study is exploring early QoR after radical prostatectomy in the two groups of anesthesia. The first group had a light general anesthesia with lumbal epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2021-04-01
- Completion
- 2021-06-01
Publications
- Background Greg Snow (2020) blockrand: Randomization for Block Random Clinical Trials. R package version 1.5. https://CRAN.R-project.org/package=blockrand
- Background Stamer UM, Hothker F, Lehnen K, Stuber F. [Postoperative analgesia with tramadol and metamizol. Continual infusion versus patient controlled analgesia]. Anaesthesist. 2003 Jan;52(1):33-41. doi: 10.1007/s00101-002-0427-1. German.
- Background Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.
- Background Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
- Background Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- Background Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.
- Background Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.
- Background Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 0.4 mg/ml | Other |
| Comparator | Ropivacaine | Other / unclassified | 2.2 mg/ml | Other |
| Comparator | Tramadol | Other / unclassified | 300 mg | Intravenous |
Indications
No indication recorded.