Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.

Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain

The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section

Study Overview

• Status: Suspended
• Conditions: Post-operative Pain
• Intervention / Treatment: Procedure: erector spinae plane block (ESP); Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Able to consent
• BMI<35

Exclusion Criteria:

• Adults unable to consent
• BMI>35
• Individuals <18 years of age at time of admission
• Individuals taking anticoagulant medications
• Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
• Pre-existing chronic pain or pain disorder diagnosis
• Conversion from neuraxial to general anesthesia
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erector spinae plane block; participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block	Procedure: erector spinae plane block (ESP); nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.; Drug: Duramorph; 100 micrograms (mcg) of morphine administered in the spinal medications one time.; Drug: Ropivacaine; Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.; Drug: Bupivacaine Injection; Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.
Experimental: standard of care; participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.	Drug: Duramorph; 100 micrograms (mcg) of morphine administered in the spinal medications one time.; Drug: Ropivacaine; Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.; Drug: Bupivacaine Injection; Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative opioid analgesic medication	measurement (milligrams)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in post-operative pain medication by visual analog scale	Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain)	baseline, up to 24 hours
number of minutes to first use of rescue medication	the number of minutes calculated using the kaplan-meier. Calculated using the number of patients that did not need the rescue analgesic at the start of each day post-surgery, and the number of patients who needed the rescue analgesic.	up to 24 hours
obstetric quality of recovery scale	responses range from 0-10. zero is strongly agree, strongly disagree.	up to 24 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Reine Zbeidy, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2024
• Primary Completion (Estimated): September 10, 2024
• Study Completion (Estimated): September 10, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Ropivacaine; Morphine
• Other Study ID Numbers: 20230857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No