Stopping Opioid Overuse in Obstetrics To Halt Exposure Trial

Study Overview
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Brief Summary
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As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.

Detailed Description
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Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill that prescription and 1% continue to use those opioids 90 days after delivery despite no longer requiring them for pain control, predisposing them to opioid dependence. This study aims to determine if transverse abdominis plane (TAP) block using bupivacaine liposome suspension injection (EXPAREL®) significantly reduces the use of opioid medications after discharge in women undergoing scheduled cesarean delivery. The study is a proposed double-blinded, randomized controlled trial. Pregnant women who have completed 37 weeks gestation and are scheduled for cesarean delivery will be randomized to receive a TAP block with 80 ml of mixed liposomal bupivacaine or saline. Based on its use in other surgical settings, the investigators hypothesize that women who receive a liposomal bupivacaine TAP block will use significantly less opioids by postoperative day 7 as calculated in morphine milligram equivalents. In addition to overall consumption of opioids after discharge, other aims to be studied include inpatient opioid use, effect on pain scores, rates of postpartum depression, patient-perceived quality of breastfeeding, patient quality of recovery, and composite adverse outcomes. With better overall pain control and less dependence on opioids postpartum, liposomal bupivacaine TAP blocks at the time of scheduled cesarean delivery may offer a highly effective analgesic alternative that can help shift the tide in the ongoing opioid epidemic among reproductive females.

Official Title
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Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial

Conditions
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Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Procedure: TAP block
* Drug: Deposition of saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unlabored, scheduled primary or repeat cesarean delivery Cesarean performed by obstetrician or surgically-trained family medicine physician Ability to complete numeric pain scale assessment and surveys Patients who do not speak English but are able to converse via an interpreter both in person and by phone Exclusion Criteria: Complications requiring return to the operating room Unscheduled deliveries <18 years old, >45 years old Twin deliveries Preterm deliveries (<37 wks) Current or previous history of opioid-substance use disorder according to patient report or medical chart Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program Allergy to local anesthetics or NSAIDs Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement Known significant renal disease, oliguria, or Cr >1.1. Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy Infection overlying the regional anesthesia site Hypovolemia prohibiting regional anesthesia General anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right. | Drug: Liposomal bupivacaine<br>* Deposition of liposomal bupivacaine<br>* Other names: EXPAREL;Procedure: TAP block<br>* Transversus abdominis plane block performed to deposit anesthetic<br>|
| Placebo Comparator: Control<br>The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side). | Procedure: TAP block<br>* Transversus abdominis plane block performed to deposit anesthetic<br>Drug: Deposition of saline<br>* Deposition of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Milligram Equivalents | Amount of opioid medications taken converted to Morphine Milligram Equivalents | 7 days after cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Milligram Equivalents at 48 hours | Total opioid use inpatient at 48 hours as measured in Morphine Milligram Equivalents | Time surgery is complete to 48 hours | 
| Numeric Rating Scale Pain Score on postoperative day 1 | Highest documented pain score postoperative day #1 by Numeric Rating Scale Pain level [0-10]. Higher scores denote more pain. | Midnight to midnight postoperative day #1 | 
| Time to as needed opioid use | Time to first as needed opioid use while inpatient | Inpatient stay up to 6 days | 
| Opioid-spared Percentage | Percentage of patients in each arm that did not receive any additional opioid after surgery | Inpatient stay up to 6 days | 
| Edinburgh Postpartum Depression Scale Score at Discharge | Score on the Edinburgh Postpartum Depression scale [0-30] at discharge. Higher scores denote worse depression. A positive question 10 is also positive. | Inpatient stay up to 6 days | 
| Edinburgh Postpartum Depression Scale Score at 7 days | Score on the Edinburgh Postpartum Depression scale [0-30] by phone interview postoperative day #7. Higher scores denote worse depression. A positive question 10 is also positive. | Postoperative day #7 | 
| Edinburgh Postpartum Depression Scale Score at 14 days | Score on the Edinburgh Postpartum Depression scale [0-30] at appointment postoperative day #14. Higher scores denote worse depression. A positive question 10 is also positive. | Postoperative day #14 | 
| Edinburgh Postpartum Depression Scale Score at 6 wks | Score on the Edinburgh Postpartum Depression scale [0-30] at 6 week postoperative appointment. Higher scores denote worse depression. A positive question 10 is also positive. | 6 weeks postpartum visit | 
| Numeric Rating Scale Pain Score Postoperative day #7 | Numeric Rating Scale Pain level [0-10] assessed by phone interview on Postoperative day #7. Higher scores denote more pain. | Postoperative day #7 | 
| Numeric Rating Scale Pain Score at Postoperative day #14 | Numeric Rating Scale Pain level [0-10] at 2 week post op visit. Higher scores denote more pain. | Postoperative day #14 | 
| Numeric Rating Scale Pain Score at 6 wks | Numeric Rating Scale Pain level [0-10] at 6 week post op visit. Higher scores denote more pain. | Postpartum visit 6 wks | 
| Quality of Recovery-15 at discharge | Quality of Recovery scale at discharge | Inpatient stay up to 6 days | 
| Quality of Recovery-15 at 7 day | Quality of Recovery scale at Postoperative day #7 by phone interview [0-150].The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively. | Postoperative day #7 | 
| Quality of Recovery-15 at Postoperative day #14 | Quality of Recovery scale at post op visit [0-150]. The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively. | Postoperative day #14 | 
| Quality of Recovery-15 at 6 weeks | Quality of Recovery scale at postpartum visit [0-150].The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively. | Postpartum visit 6 weeks | 
| Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7 | Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7 by phone interview [14-70] with higher scores denoting higher confidence | Postoperative day #7 | 
| Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14 | Breastfeeding Self-Efficacy Scale Short Form at post op visit [14-70] with higher scores denoting higher confidence | Postoperative day #14 | 
| Breastfeeding Self-Efficacy Scale Short Form at 6 weeks | Breastfeeding Self-Efficacy Scale Short Form at postpartum visit [14-70] with higher scores denoting higher confidence | Postpartum 6 weeks | 
| Adverse Events | Adverse outcomes or side effects | Study duration   8 weeks |