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

Sponsor
McMaster University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04202874
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgeon-administered transversus abdominis plane (TAP)
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Total dose of opioid (in morphine equivalents) received in the postoperative period [24 hours after surgery]

Secondary Outcome Measures

  1. Postoperative pain scores [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).

  2. Postoperative nausea and vomiting rates [postoperative day 1]

    As defined by the Simplified Postoperative Nausea and Vomiting (PONV) impact scale

  3. Time to flatus [During admission]

    In hours

  4. Incidence of clinical ileus [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.

  5. Time to discharge from hospital [During admission]

    In hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Juravinski Hospital Hamilton Ontario Canada

Sponsors and Collaborators

  • McMaster University

Investigators

  • Principal Investigator: Clare Reade, MD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laurence Bernard, Fellow, Gynecology Oncology, McMaster University
ClinicalTrials.gov Identifier:
NCT04202874
Other Study ID Numbers:
  • 8302
First Posted:
Dec 18, 2019
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Laurence Bernard, Fellow, Gynecology Oncology, McMaster University
randomized controlled trial
Transversus Abdominis Plane block
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Nov 17, 2021