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

November 16, 2021 updated by: Laurence Bernard, McMaster University

A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. While ultrasound-guided Transversus Abdominis Plane (TAP) block has been shown to reduce postoperative opioid use, the time and expertise needed to perform it can be a barrier to administering the procedure. A surgeon-administered TAP block has been described, but has yet to be evaluated with a randomized controlled study in gynecology oncology patients undergoing a midline laparotomy. The investigators hypothesize that surgeon-administered TAP blocks may decrease total opioid use in the first 24 hours.

Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited to undergo bilateral surgeon-administered TAP blocks with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides, prior to fascial closure. Exclusion criteria include inability to give informed consent, presence of contraindications or sensitivities to drugs specified in the protocol, pre-existing truncal sensory disturbance, history of chronic opioid use, infections at the injection site, significant adhesions on the anterior or lateral abdominal wall preventing access to the injection site, patients receiving neuraxial anesthesia (Epidural, Spinal) or local wound infiltration. The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. 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.

Sample size calculation was based on a meta-analysis by Johns for use of TAP blocks in abdominal surgeries, that reported morphine equivalents mean at 24h as 20.6mg for the TAP group and 44.3mg for the control group (mean difference of 23mg in 24h), with a standard deviation of 14mg. To find a clinically significant decrease in opioid use of 20%, our primary outcome, with a 2-tailed analysis and power of 80%; the investigators would need 36 patients in each group. To account for potential dropouts and protocol violations, as well as secondary analyses, the investigators will recruit a total of 80 patients (40 in the TAP block group and 40 controls).

Differences in characteristics between treatment and control groups will be analysed using the chi-square test for dichotomous data, independent samples Student's t-test for parametric continuous variables, and Mann-Whitney U test for non-parametric continuous data. Test of normality will be performed using the Shapiro-Wilk test. If there is significant (>10%) missing data, data will be imputed by predictive mean matching. Subgroup analysis by type of incision (infraumbilical vs supraumbilical) will be performed.

Missing data and patterns will be assessed monthly by the data manager. Remedial measures, including retraining of staff, will be used as needed to minimize missing data. The investigators plan for an intention-to-treat analysis.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bupivacaine
Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml.
Procedure: Surgeon-administered transversus abdominis plane (TAP)
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.
PLACEBO_COMPARATOR: Saline
Administration on 20ml of normal saline on each side, for a total of 40ml.
Procedure: Surgeon-administered transversus abdominis plane (TAP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total dose of opioid (in morphine equivalents) received in the postoperative period
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
Numerical Pain Rating Scale, from 0 to 10. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
Postoperative nausea and vomiting rates
Time Frame: postoperative day 1
As defined by the Simplified Postoperative Nausea and Vomiting (PONV) impact scale
postoperative day 1
Time to flatus
Time Frame: During admission
In hours
During admission
Incidence of clinical ileus
Time Frame: During admission
as a surgeon's diagnosis of postoperative ileum, including diagnosis on abdominal x-ray, return to nothing-by-mouth status, or (re)insertion of a nasogastric tube.
During admission
Time to discharge from hospital
Time Frame: During admission
In hours
During admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Clare Reade, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8302 (CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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