ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicholas Schott
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Elective cesarean planned under spinal anesthesia

• Singleton pregnancy

• American Society of Anesthesiologists (ASA) classification score of 2 (or less)

• Gestational age of at least 37 weeks

• Intention to breastfeed infant

Exclusion Criteria:

• Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)

• Anatomical abnormalities contraindicating spinal or QLB placement

• Received/Conversion to general anesthesia

• Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)

• History of chronic pain

• History of chronic opioid use/abuse

• History of Subutex, methadone, other maintenance therapy