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Clinical Trials/NCT04256642
NCT04256642
Unknown
Phase 3

Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country160 target enrollmentFebruary 2020

Overview

Phase
Phase 3
Intervention
Intrathecal morphine
Conditions
Cesarean Section Complications
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
160
Locations
1
Primary Endpoint
24 hour area under the curve pain scores
Last Updated
6 years ago

Overview

Brief Summary

This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.

Registry
clinicaltrials.gov
Start Date
February 2020
End Date
January 2023
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Albert Moore

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing scheduled Cesarean delivery

Exclusion Criteria

  • Patients with an ASA score greater than 3
  • Allergies to study medications
  • Contraindications to neuraxial analgesia
  • Patients with chronic pain
  • Patients unable to communicate in the study language

Arms & Interventions

Intrathecal morphine

Intervention: Intrathecal morphine

Erector Spinae Plane Block

Intervention: Erector Spinae Plane Block

Outcomes

Primary Outcomes

24 hour area under the curve pain scores

Time Frame: First 24 hour

It will be measured at 3 6 12 18 and 24 hours after the end of the cesarean delivery. This pain will be assessed by asking the patient to go from lying to sitting (or use incentive spirometry) and rated using a linear 10 cm visual analogue scale (VAS). The 24 hour pain VAS area under the curve (AUC) will be calculated using the trapezoid rule.

Secondary Outcomes

  • Measurement of quality of recovery after cesarean delivery(First 24 hours)
  • Pruritus(First 24 hours)
  • Incidente of persistent surgical pain(Three months)
  • Analgesic usage(First 24 hours)
  • Nausea and vomiting(First 24 hours)

Study Sites (1)

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