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Clinical Trials/NCT06114121
NCT06114121
Suspended
Phase 4

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

University of Miami0 sites100 target enrollmentJuly 10, 2024

Overview

Phase
Phase 4
Intervention
erector spinae plane block (ESP)
Conditions
Post-operative Pain
Sponsor
University of Miami
Enrollment
100
Primary Endpoint
post-operative opioid analgesic medication
Status
Suspended
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
September 10, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reine Zbeidy

Associate Professor of Clinical Anesthesiology

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Adults unable to consent
  • 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

Arms & Interventions

erector spinae plane block

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

Intervention: erector spinae plane block (ESP)

erector spinae plane block

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

Intervention: Duramorph

erector spinae plane block

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

Intervention: Ropivacaine

erector spinae plane block

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

Intervention: Bupivacaine Injection

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.

Intervention: Duramorph

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.

Intervention: Ropivacaine

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.

Intervention: Bupivacaine Injection

Outcomes

Primary Outcomes

post-operative opioid analgesic medication

Time Frame: up to 24 hours

measurement (milligrams)

Secondary Outcomes

  • 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)

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