Clinical trial NCT04202874: A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Official title: A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Genital Neoplasm Malignant Female
Surgical Procedure, Unspecified
Keywords: randomized controlled trial
Transversus Abdominis Plane block
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total dose of opioid (in morphine equivalents) received in the postoperative period
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
measure: Postoperative nausea and vomiting rates
timeFrame: postoperative day 1
measure: Time to flatus
timeFrame: During admission
measure: Incidence of clinical ileus
timeFrame: During admission
measure: Time to discharge from hospital
timeFrame: During admission
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Clare Reade, MD
role: PRINCIPAL_INVESTIGATOR
References:
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