Clinical trial NCT04680221: Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
Official title: Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Opioid Use
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Truman Medical Center
First posted: 2020-12-22
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine Milligram Equivalents
timeFrame: 7 days after cesarean
Secondary outcomes:
measure: Morphine Milligram Equivalents at 48 hours
timeFrame: Time surgery is complete to 48 hours
measure: Numeric Rating Scale Pain Score on postoperative day 1
timeFrame: Midnight to midnight postoperative day #1
measure: Time to as needed opioid use
timeFrame: Inpatient stay up to 6 days
measure: Opioid-spared Percentage
timeFrame: Inpatient stay up to 6 days
measure: Edinburgh Postpartum Depression Scale Score at Discharge
timeFrame: Inpatient stay up to 6 days
measure: Edinburgh Postpartum Depression Scale Score at 7 days
timeFrame: Postoperative day #7
measure: Edinburgh Postpartum Depression Scale Score at 14 days
timeFrame: Postoperative day #14
measure: Edinburgh Postpartum Depression Scale Score at 6 wks
timeFrame: 6 weeks postpartum visit
measure: Numeric Rating Scale Pain Score Postoperative day #7
timeFrame: Postoperative day #7
measure: Numeric Rating Scale Pain Score at Postoperative day #14
timeFrame: Postoperative day #14
measure: Numeric Rating Scale Pain Score at 6 wks
timeFrame: Postpartum visit 6 wks
measure: Quality of Recovery-15 at discharge
timeFrame: Inpatient stay up to 6 days
measure: Quality of Recovery-15 at 7 day
timeFrame: Postoperative day #7
measure: Quality of Recovery-15 at Postoperative day #14
timeFrame: Postoperative day #14
measure: Quality of Recovery-15 at 6 weeks
timeFrame: Postpartum visit 6 weeks
measure: Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7
timeFrame: Postoperative day #7
measure: Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14
timeFrame: Postoperative day #14
measure: Breastfeeding Self-Efficacy Scale Short Form at 6 weeks
timeFrame: Postpartum 6 weeks
measure: Adverse Events
timeFrame: Study duration ~ 8 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center - Lakewood
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Devika Maulik, MD
role: STUDY_CHAIR
affiliation: University of Missouri, Kansas City
name: Gary Sutkin, MD
role: STUDY_CHAIR
References:
citation: Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.
citation: Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
citation: Badreldin N, Grobman WA, Chang KT, Yee LM. Opioid prescribing patterns among postpartum women. Am J Obstet Gynecol. 2018 Jul;219(1):103.e1-103.e8. doi: 10.1016/j.ajog.2018.04.003. Epub 2018 Apr 7.
citation: Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
citation: Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A Critical Review of Available Instruments. J Hum Lact. 2016 Feb;32(1):35-45. doi: 10.1177/0890334415599533. Epub 2015 Aug 28.
citation: Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
citation: Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
citation: Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
citation: Babazade R, Vadhera RB, Krishnamurthy P, Varma A, Doulatram G, Saade GR, Turan A. Acute postcesarean pain is associated with in-hospital exclusive breastfeeding, length of stay and post-partum depression. J Clin Anesth. 2020 Jun;62:109697. doi: 10.1016/j.jclinane.2019.109697. Epub 2019 Dec 31.
citation: Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.
citation: Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.