Status:

TERMINATED

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

Lead Sponsor:

Nicholas Schott

Conditions:

Pain, Postoperative

Eligibility:

FEMALE

18-45 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 5 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 11 2022

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT03261193

Start Date

September 5 2017

End Date

November 11 2022

Last Update

May 6 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

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