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

Phase 3

• Conditions: Cesarean Section Complications
• Interventions: Drug: Intrathecal morphine; Procedure: Erector Spinae Plane Block

• Registration Number: NCT04256642
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-30
• Status Verified: 2020-02
• Study Start: 2020-02
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Intrathecal morphine	-
Erector Spinae Plane Block	Erector Spinae Plane Block	-

Primary Outcome Measures

Name	Time	Method
24 hour area under the curve pain scores	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 Outcome Measures

Name	Time	Method
Measurement of quality of recovery after cesarean delivery	First 24 hours	At 24 hours the ObsQoR11, a validated instrument to measure the quality of recovery after cesarean delivery, will be administered to the patient
Pruritus	First 24 hours	The incidence of pruritus will be rated on a 10 cm VAS
Incidente of persistent surgical pain	Three months	Patients will be contacted by telephone 3 months after the cesarean to assess the presence of chronic pain. This will be done using a modification of the brief pain inventory
Analgesic usage	First 24 hours	The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours.
Nausea and vomiting	First 24 hours	The incidence of nausea and vomiting will be rated on a 10 cm VAS

Trial Locations

Locations (1)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada