A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Sponsor study identifier
interventional
80
1 country
1
Study Start
October 1, 2020
Actual (reported)Primary Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. Administration by the surgeon of local anesthetics in the abdominal wall after surgery for a suspected gynaecological malignancy will be studied. Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited. Half of these women will received a Transversus Abdominis Plane (TAP) block using local anesthetics, and half will receive a placebo (saline water). The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. The primary hypothesis is that surgeon-performed TAP blocks reduce the need for opioids after surgery. Secondary outcomes including postoperative pain scores, postoperative nausea and vomiting rates, time to flatus, incidence of clinical ileus and time to discharge from hospital will also be recorded.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2019
Actual (reported)December 18, 2019
Actual (reported)October 1, 2020
Actual (reported)November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total dose of opioid (in morphine equivalents) received in the postoperative period
24 hours after surgery
Postoperative pain scores
at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
Postoperative nausea and vomiting rates
postoperative day 1
Time to flatus
During admission
Incidence of clinical ileus
During admission
Time to discharge from hospital
During admission
Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml.
Administration on 20ml of normal saline on each side, for a total of 40ml.
Prior to fascial closure, the rectus muscle is gently elevated superiorly and the surgeon identifies its lateral border; the nerves that supply the anterior abdominal wall travel through the myofascial plane between internal oblique and transversus abdominis muscles, 2 fingerbreadths above the iliac crest. Access to this plane can easily be achieved by inserting a blunted needle through the parietal peritoneum; there is an appreciable loss of resistance ('one pop') and the correct plane is entered. After careful aspiration to ensure no vascular injury has occurred, 20 mL 0.25% bupivacaine or 20 mL of normal saline is injected slowly. The same procedure is repeated on the other side.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Juravinski Hospital
Hamilton, Ontario, Canada
Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
Clare Reade, MD
McMaster University
80 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2019
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Contact the study team to confirm eligibility.
McDermott G, Korba E, Mata U, Jaigirdar M, Narayanan N, Boylan J, Conlon N. Should we stop doing blind transversus abdominis plane blocks? Br J Anaesth. 2012 Mar;108(3):499-502. doi: 10.1093/bja/aer422. Epub 2012 Jan 11.
Owen DJ, Harrod I, Ford J, Luckas M, Gudimetla V. The surgical transversus abdominis plane block--a novel approach for performing an established technique. BJOG. 2011 Jan;118(1):24-7. doi: 10.1111/j.1471-0528.2010.02779.x. Epub 2010 Nov 18.
Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.
Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
Chang H, Rimel BJ, Li AJ, Cass I, Karlan BY, Walsh C. Ultrasound guided transversus abdominis plane (TAP) block utilization in multimodal pain management after open gynecologic surgery. Gynecol Oncol Rep. 2018 Oct 15;26:75-77. doi: 10.1016/j.gore.2018.10.007. eCollection 2018 Nov.
Narasimhulu DM, Scharfman L, Minkoff H, George B, Homel P, Tyagaraj K. A randomized trial comparing surgeon-administered intraoperative transversus abdominis plane block with anesthesiologist-administered transcutaneous block. Int J Obstet Anesth. 2018 Aug;35:26-32. doi: 10.1016/j.ijoa.2018.04.007. Epub 2018 Apr 27.
Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
Kaye AD, Urman RD, Rappaport Y, Siddaiah H, Cornett EM, Belani K, Salinas OJ, Fox CJ. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S40-S45. doi: 10.4103/joacp.JOACP_51_18.
Bakkum-Gamez JN, Langstraat CL, Martin JR, Lemens MA, Weaver AL, Allensworth S, Dowdy SC, Cliby WA, Gostout BS, Podratz KC. Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma. Gynecol Oncol. 2012 Jun;125(3):614-20. doi: 10.1016/j.ygyno.2012.02.027. Epub 2012 Feb 24.
Bernard L, Lavecchia M, Trepanier G, Mah S, Pokoradi A, McGinnis JM, Alyafi M, Glezerson B, Nguyen J, Carlson V, Helpman L, Elit L, Jimenez W, Eiriksson L, Reade CJ. A double-blinded, randomized trial comparing surgeon-administered transversus abdominis plane block with placebo after midline laparotomy in gynecologic oncology surgery. Am J Obstet Gynecol. 2023 May;228(5):553.e1-553.e8. doi: 10.1016/j.ajog.2023.02.010. Epub 2023 Feb 14.
First Posted
December 18, 2019
Study Start
October 1, 2020
Actual (reported)Primary Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 17, 2021
Record last verified: 2021-11
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