Opioid Use, Pain, Postoperative
Conditions
Brief summary
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
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.
Interventions
DRUGLiposomal bupivacaine
Deposition of liposomal bupivacaine
PROCEDURETAP block
Transversus abdominis plane block performed to deposit anesthetic
DRUGDeposition of saline
Deposition of saline
Sponsors
Truman Medical Center
University of Missouri, Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalents | 7 days after cesarean | Amount of opioid medications taken converted to Morphine Milligram Equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale Pain Score on postoperative day 1 | Midnight to midnight postoperative day #1 | Highest documented pain score postoperative day #1 by Numeric Rating Scale Pain level \[0-10\]. Higher scores denote more pain. |
| Time to as needed opioid use | Inpatient stay up to 6 days | Time to first as needed opioid use while inpatient |
| Opioid-spared Percentage | Inpatient stay up to 6 days | Percentage of patients in each arm that did not receive any additional opioid after surgery |
| Edinburgh Postpartum Depression Scale Score at Discharge | Inpatient stay up to 6 days | Score on the Edinburgh Postpartum Depression scale \[0-30\] at discharge. Higher scores denote worse depression. A positive question 10 is also positive. |
| Edinburgh Postpartum Depression Scale Score at 7 days | Postoperative day #7 | 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. |
| Edinburgh Postpartum Depression Scale Score at 14 days | Postoperative day #14 | 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. |
| Edinburgh Postpartum Depression Scale Score at 6 wks | 6 weeks postpartum visit | 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. |
| Numeric Rating Scale Pain Score Postoperative day #7 | Postoperative day #7 | Numeric Rating Scale Pain level \[0-10\] assessed by phone interview on Postoperative day #7. Higher scores denote more pain. |
| Numeric Rating Scale Pain Score at Postoperative day #14 | Postoperative day #14 | Numeric Rating Scale Pain level \[0-10\] at 2 week post op visit. Higher scores denote more pain. |
| Morphine Milligram Equivalents at 48 hours | Time surgery is complete to 48 hours | Total opioid use inpatient at 48 hours as measured in Morphine Milligram Equivalents |
| Quality of Recovery-15 at discharge | Inpatient stay up to 6 days | Quality of Recovery scale at discharge |
| Quality of Recovery-15 at 7 day | Postoperative day #7 | 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. |
| Quality of Recovery-15 at Postoperative day #14 | 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. |
| Quality of Recovery-15 at 6 weeks | Postpartum visit 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. |
| Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7 | Postoperative day #7 | Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7 by phone interview \[14-70\] with higher scores denoting higher confidence |
| Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14 | Postoperative day #14 | Breastfeeding Self-Efficacy Scale Short Form at post op visit \[14-70\] with higher scores denoting higher confidence |
| Breastfeeding Self-Efficacy Scale Short Form at 6 weeks | Postpartum 6 weeks | Breastfeeding Self-Efficacy Scale Short Form at postpartum visit \[14-70\] with higher scores denoting higher confidence |
| Adverse Events | Study duration ~ 8 weeks | Adverse outcomes or side effects |
| Numeric Rating Scale Pain Score at 6 wks | Postpartum visit 6 wks | Numeric Rating Scale Pain level \[0-10\] at 6 week post op visit. Higher scores denote more pain. |
Countries
United States
Outcome results
None listed