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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06114121
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 25.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain	Procedure: erector spinae plane block (ESP); Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain
• Anticipated Study Start Date: Jan 10, 2024
• Anticipated Primary Completion Date: May 10, 2024
• Anticipated Study Completion Date: May 10, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. post-operative opioid analgesic medication [up to 24 hours]

   measurement (milligrams)

Secondary Outcome Measures

1. change in post-operative pain medication by visual analog scale [baseline, up to 24 hours]

   Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain)

2. number of minutes to first use of rescue medication [up to 24 hours]

   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.

3. obstetric quality of recovery scale [up to 24 hrs]

   responses range from 0-10. zero is strongly agree, strongly disagree.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reine Zbeidy, Associate Professor of Clinical Anesthesiology, University of Miami
• ClinicalTrials.gov Identifier: NCT06114121
• Other Study ID Numbers: 20230857
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Reine Zbeidy, Associate Professor of Clinical Anesthesiology, University of Miami: erector spinae plane block
• Additional relevant MeSH terms: Pain, Postoperative; Morphine; Bupivacaine; Ropivacaine

Study Results

No Results Posted as of Nov 2, 2023