drugset / Trial / NCT02483689
Evaluation of Local Anesthetic at Incision Site
RandomizedParallel-groupTriple-blindTreatment
Summary
Patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random. The clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied. Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess the timing of local anesthetic injection affects postoperative pain.
Timeline
- Start
- 2015-08
- Primary completion
- 2020-07
- Completion
- 2020-07
Publications
- Background Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.
- Background Buckius MT, McGrath B, Monk J, Grim R, Bell T, Ahuja V. Changing epidemiology of acute appendicitis in the United States: study period 1993-2008. J Surg Res. 2012 Jun 15;175(2):185-90. doi: 10.1016/j.jss.2011.07.017. Epub 2011 Aug 9.
- Background Edwards TJ, Carty SJ, Carr AS, Lambert AW. Local anaesthetic wound infiltration following paediatric appendicectomy: a randomised controlled trial: Time to stop using local anaesthetic wound infiltration following paediatric appendicectomy? Int J Surg. 2011;9(4):314-7. doi: 10.1016/j.ijsu.2010.09.012. Epub 2011 Feb 13.
- Background Kang H, Kim BG. Intraperitoneal ropivacaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. J Int Med Res. 2010 May-Jun;38(3):821-32. doi: 10.1177/147323001003800309.
- Background Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
- Background Masoomi H, Nguyen NT, Dolich MO, Mills S, Carmichael JC, Stamos MJ. Laparoscopic appendectomy trends and outcomes in the United States: data from the Nationwide Inpatient Sample (NIS), 2004-2011. Am Surg. 2014 Oct;80(10):1074-7.
- Background Oravsky M, Bak V, Schnorrer M. Laparoscopic versus open appendectomy in treatment of acute appendicitis. Bratisl Lek Listy. 2014;115(10):660-2. doi: 10.4149/bll_2014_127.
- Background Palmes D, Rottgermann S, Classen C, Haier J, Horstmann R. Randomized clinical trial of the influence of intraperitoneal local anaesthesia on pain after laparoscopic surgery. Br J Surg. 2007 Jul;94(7):824-32. doi: 10.1002/bjs.5810.
- Background Reynolds SL, Jaffe DM. Diagnosing abdominal pain in a pediatric emergency department. Pediatr Emerg Care. 1992 Jun;8(3):126-8. doi: 10.1097/00006565-199206000-00003.
- Background Scholer SJ, Pituch K, Orr DP, Dittus RS. Clinical outcomes of children with acute abdominal pain. Pediatrics. 1996 Oct;98(4 Pt 1):680-5.
- Background Thanapal MR, Tata MD, Tan AJ, Subramaniam T, Tong JM, Palayan K, Rampal S, Gurunathan R. Pre-emptive intraperitoneal local anaesthesia: an effective method in immediate post-operative pain management and metabolic stress response in laparoscopic appendicectomy, a randomized, double-blinded, placebo-controlled study. ANZ J Surg. 2014 Jan-Feb;84(1-2):47-51. doi: 10.1111/j.1445-2197.2012.06210.x. Epub 2012 Oct 11.
- Background Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
- Background Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature. 1983 Dec 15-21;306(5944):686-8. doi: 10.1038/306686a0.
- Background Wright JE. Controlled trial of wound infiltration with bupivacaine for postoperative pain relief after appendicectomy in children. Br J Surg. 1993 Jan;80(1):110-1. doi: 10.1002/bjs.1800800136.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivicaine | Other / unclassified | 0.25 % | Other |