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

Cesarean Section Complications Clinical Trial

— ESPCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256642
• Other study ID #: 2020-5732
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2020
• Est. completion date: January 2023

Study information

• Verified date: February 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Albert Moore, MD
• Phone: 5149341934
• Email: albert.moore[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• Erector Spinae Plane Block
A nerve block that injects local anesthetic in the Erector Spinae Plane

Drug:
• Intrathecal morphine
Intrathecal morphine at the time of spinal anesthesia

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Thammasat University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour area under the curve pain scores	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.	First 24 hour
Secondary	Measurement of quality of recovery after cesarean delivery	At 24 hours the ObsQoR11, a validated instrument to measure the quality of recovery after cesarean delivery, will be administered to the patient	First 24 hours
Secondary	Nausea and vomiting	The incidence of nausea and vomiting will be rated on a 10 cm VAS	First 24 hours
Secondary	Analgesic usage	The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours.	First 24 hours
Secondary	Pruritus	The incidence of pruritus will be rated on a 10 cm VAS	First 24 hours
Secondary	Incidente of persistent surgical pain	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	Three months