A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology

NCT04202874 | Unknown Phase 3

• 1 other identifier: 8302
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genital Neoplasm Malignant Female; Surgical Procedure, Unspecified

Keywords

randomized controlled trial; Transversus Abdominis Plane block

Outcome Measures

Primary Outcomes (1)

• Total dose of opioid (in morphine equivalents) received in the postoperative period

  24 hours after surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml.

Procedure: Surgeon-administered transversus abdominis plane (TAP)

Saline

PLACEBO COMPARATOR

Administration on 20ml of normal saline on each side, for a total of 40ml.

Procedure: Surgeon-administered transversus abdominis plane (TAP)

Interventions

Surgeon-administered transversus abdominis plane (TAP) PROCEDURE

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.

Bupivacaine; Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above undergoing elective gynecologic oncology surgery for a suspected malignancy using a midline laparotomy incision.

You may not qualify if:

• Patients unable to give informed consent
• Patients with contraindications or sensitivities to drugs specified in the protocol
• Pre-existing truncal sensory disturbance
• History of chronic opioid use (daily use \> 3 months)
• Infections at the injection site
• Significant adhesions on the anterior abdominal wall preventing access to the injection site
• Concurrent, non-abdominal surgical procedure performed at the same time
• Patients receiving neuraxial anesthesia/analgesia (epidural, spinal) or local wound infiltration

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, Canada

Location

Related Publications (15)

• 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.

  PMID: 30877144 BACKGROUND

• 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.

  PMID: 11576144 BACKGROUND

• 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.

  PMID: 22236911 BACKGROUND

• 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.

  PMID: 21083866 BACKGROUND

• 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.

  PMID: 28472015 BACKGROUND

• 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.

  PMID: 26397443 BACKGROUND

• 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.

  PMID: 21154380 BACKGROUND

• 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.

  PMID: 22632762 BACKGROUND

• 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.

  PMID: 21296242 BACKGROUND

• 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.

  PMID: 30364775 BACKGROUND

• 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.

  PMID: 29914782 BACKGROUND

• 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.

  PMID: 22156268 BACKGROUND

• 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.

  PMID: 31142958 BACKGROUND

• 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.

  PMID: 22370599 BACKGROUND

• 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.

  PMID: 36791986 DERIVED

Study Officials

• Clare Reade, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient, surgeon, anesthesiologist, scrub nurse and outcome assessors will be blinded. The operating room circulating nurse, who will be providing the substance, will be unblinded. The investigators will be unblinded after data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Gynecology Oncology

Model Details: Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be randomized to undergo a bilateral surgeon-administered Tranversus abdomens plane block with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides (placebo), prior to fascial closure. Forty patient will receive bupivacaine, and 40 patients will receive the placebo.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: October 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)