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

University of Miami

Status and phase: Withdrawn; Phase 4

Conditions: Post-operative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06114121

20230857

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

erector spinae plane block

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Procedure: erector spinae plane block (ESP)

Drug: Bupivacaine Injection

Drug: Duramorph

standard of care

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Bupivacaine Injection

Drug: Duramorph