drugset / Trial / NCT03809442
Analgesic Efficacy of Ropivacaine Alone or in Combination With Adjuvants on Post-operative Analgesia Following Video-Assisted Thoracoscopic Surgery.
RandomizedParallel-groupTriple-blindTreatment
Summary
The aim of the study is to investigate the analgesic effects of the subcutaneous wound infiltration with tramadol, ketamine, dexamethasone, dexmedetomidine and midazolam as adjuvant to ropivacaine, compared to ropivacaine alone in patients undergoing Video-Assisted thoracoscopic Surgery (VATS) procedures.
Timeline
- Start
- 2019-06-25
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
Publications
- Background Sommer M, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Geurts JW, Gramke HF, Marcus MA. The prevalence of postoperative pain in a sample of 1490 surgical inpatients. Eur J Anaesthesiol. 2008 Apr;25(4):267-74. doi: 10.1017/S0265021507003031. Epub 2007 Dec 6.
- Background Bernucci F, Carli F. Functional outcome after major orthopedic surgery: the role of regional anesthesia redefined. Curr Opin Anaesthesiol. 2012 Oct;25(5):621-8. doi: 10.1097/ACO.0b013e328357a3d5.
- Background Bafna U, Sharma G, Sapru S, et al. Comparison of clonidine anddexmedetomidine as an adjuvant to 0.5% ropivacaine in supraclavicularbrachial plexus block: a prospective, randomized,doubleblindand controlled study. J Recent Adv Pain. 2015;1:73-77.
- Background Ng A, Swami A, Smith G, Davidson AC, Emembolu J. The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. Anesth Analg. 2002 Jul;95(1):158-62, table of contents. doi: 10.1097/00000539-200207000-00028.
- Background Li M, Wan L, Mei W, Tian Y. Update on the clinical utility and practical use of ropivacaine in Chinese patients. Drug Des Devel Ther. 2014 Sep 9;8:1269-76. doi: 10.2147/DDDT.S57258. eCollection 2014.
- Background Pedersen JL, Galle TS, Kehlet H. Peripheral analgesic effects of ketamine in acute inflammatory pain. Anesthesiology. 1998 Jul;89(1):58-66. doi: 10.1097/00000542-199807000-00011.
- Background Tan PH, Cheng JT, Kuo CH, Tseng FJ, Chung HC, Wu JI, Hsiao HT, Yang LC. Preincisional subcutaneous infiltration of ketamine suppresses postoperative pain after circumcision surgery. Clin J Pain. 2007 Mar-Apr;23(3):214-8. doi: 10.1097/AJP.0b013e31802e3377.
- Background Lewis KS, Han NH. Tramadol: a new centrally acting analgesic. Am J Health Syst Pharm. 1997 Mar 15;54(6):643-52. doi: 10.1093/ajhp/54.6.643.
- Background Desmeules JA, Piguet V, Collart L, Dayer P. Contribution of monoaminergic modulation to the analgesic effect of tramadol. Br J Clin Pharmacol. 1996 Jan;41(1):7-12. doi: 10.1111/j.1365-2125.1996.tb00152.x.
- Background Krishnadas A, Suvarna K, Hema VR, Taznim M. A comparison of ropivacaine, ropivacaine with tramadol and ropivacaine with midazolam for post-operative caudal epidural analgesia. Indian J Anaesth. 2016 Nov;60(11):827-832. doi: 10.4103/0019-5049.193672.
- Background Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
- Background Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
- Background Reddy VS, Shaik NA, Donthu B, Reddy Sannala VK, Jangam V. Intravenous dexmedetomidine versus clonidine for prolongation of bupivacaine spinal anesthesia and analgesia: A randomized double-blind study. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):342-7. doi: 10.4103/0970-9185.117101.
- Background Mitra S, Purohit S, Sharma M. Postoperative Analgesia After Wound Infiltration With Tramadol and Dexmedetomidine as an Adjuvant to Ropivacaine for Lumbar Discectomies: A Randomized-controlled Clinical Trial. J Neurosurg Anesthesiol. 2017 Oct;29(4):433-438. doi: 10.1097/ANA.0000000000000422.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 8 mg | Subcutaneous |
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Subcutaneous |
| Subject | Ketamine | Small molecule | 1 mg/kg | Subcutaneous |
| Subject | Midazolam | Small molecule | 50 ug/kg | Subcutaneous |
| Comparator | Ropivacaine | Other / unclassified | 60 mg | Subcutaneous |
| Subject | Tramadol | Other / unclassified | 2 mg/kg | Subcutaneous |
Indications
No indication recorded.