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

Phase 4

Suspended

• Conditions: Post-operative Pain
• Interventions: Procedure: erector spinae plane block (ESP); Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection

• Registration Number: NCT06114121
• Lead Sponsor: University of Miami

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Study Start: 2024-07-10
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae plane block	Bupivacaine Injection	participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block
erector spinae plane block	erector spinae plane block (ESP)	participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block
standard of care	Bupivacaine Injection	participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.
erector spinae plane block	Ropivacaine	participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block
standard of care	Ropivacaine	participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.
erector spinae plane block	Duramorph	participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block
standard of care	Duramorph	participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.

Primary Outcome Measures

Name	Time	Method
post-operative opioid analgesic medication	up to 24 hours	measurement (milligrams)

Secondary Outcome Measures

Name	Time	Method
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)
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.
obstetric quality of recovery scale	up to 24 hours	responses range from 0-10. zero is strongly agree, strongly disagree.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States