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

NCT06114121 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20230857
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Post-operative Pain

Keywords

erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• post-operative opioid analgesic medication

  measurement (milligrams)

  up to 24 hours

Secondary Outcomes (3)

• change in post-operative pain medication by visual analog scale

  baseline, up to 24 hours

• number of minutes to first use of rescue medication

  up to 24 hours

• obstetric quality of recovery scale

  up to 24 hours

Study Arms (2)

erector spinae plane block

EXPERIMENTAL

participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block

Procedure: erector spinae plane block (ESP); Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection

standard of care

EXPERIMENTAL

participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.

Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection

Interventions

erector spinae plane block (ESP) PROCEDURE

nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.

erector spinae plane block

Duramorph DRUG

100 micrograms (mcg) of morphine administered in the spinal medications one time.

erector spinae plane block; standard of care

Ropivacaine DRUG

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.

erector spinae plane block; standard of care

Bupivacaine Injection DRUG

Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.

erector spinae plane block; standard of care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to consent
• BMI\<35

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Reine Zbeidy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: July 10, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share