Stopping Opioid Overuse in Obstetrics To Halt Exposure Trial

Pain, Postoperative Clinical Trial

— SOOOTHE  

Official title:

Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04680221
• Other study ID #: 2026221
• Secondary ID: 21-018
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 97
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine
Deposition of liposomal bupivacaine

Procedure:
• TAP block
Transversus abdominis plane block performed to deposit anesthetic

Drug:
• Deposition of saline
Deposition of saline

Locations

Country	Name	City	State
United States	Truman Medical Center - Lakewood	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	Truman Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47. — View 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. — View 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. Erratum In: JAMA Netw Open. 2019 Aug 2;2(8):e1911235. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Milligram Equivalents	Amount of opioid medications taken converted to Morphine Milligram Equivalents	7 days after cesarean
Secondary	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
Secondary	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
Secondary	Time to as needed opioid use	Time to first "as needed" opioid use while inpatient	Inpatient stay up to 6 days
Secondary	Opioid-spared Percentage	Percentage of patients in each arm that did not receive any additional opioid after surgery	Inpatient stay up to 6 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Recovery-15 at discharge	Quality of Recovery scale at discharge	Inpatient stay up to 6 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events	Adverse outcomes or side effects	Study duration ~ 8 weeks

External Links

•   CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016