Clinical trial · Interventional
A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasm Malignant Female | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgeon-administered transversus abdominis plane (TAP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bupivacaine
- description
- Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml.
- interventionNames
- Procedure: Surgeon-administered transversus abdominis plane (TAP)
- type
- PLACEBO_COMPARATOR
- label
- Saline
- description
- Administration on 20ml of normal saline on each side, for a total of 40ml.
- interventionNames
- Procedure: Surgeon-administered transversus abdominis plane (TAP)
Primary outcomes (1)
- measure
- Total dose of opioid (in morphine equivalents) received in the postoperative period
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 and above undergoing elective gynecologic oncology surgery for a suspected malignancy using a midline laparotomy incision. Exclusion Criteria: 1. Patients unable to give informed consent 2. Patients with contraindications or sensitivities to drugs specified in the protocol 3. Pre-existing truncal sensory disturbance 4. History of chronic opioid use (daily use \> 3 months) 5. Infections at the injection site 6. Significant adhesions on the anterior abdominal wall preventing access to the injection site 7. Concurrent, non-abdominal surgical procedure performed at the same time 8. Patients receiving neuraxial anesthesia/analgesia (epidural, spinal) or local wound infiltration
References
Publications (15)
- BACKGROUNDNelson 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
- BACKGROUNDRafi 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
- BACKGROUNDMcDermott 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
- BACKGROUNDOwen 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
- BACKGROUNDRavichandran 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
- BACKGROUNDBaeriswyl 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
- 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.