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

February 3, 2020 updated by: Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre
This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal morphine
Drug: Intrathecal morphine
Intrathecal morphine at the time of spinal anesthesia
Experimental: Erector Spinae Plane Block
Procedure: Erector Spinae Plane Block
A nerve block that injects local anesthetic in the Erector Spinae Plane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of quality of recovery after cesarean delivery
Time Frame: 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
First 24 hours
Nausea and vomiting
Time Frame: First 24 hours
The incidence of nausea and vomiting will be rated on a 10 cm VAS
First 24 hours
Analgesic usage
Time Frame: First 24 hours
The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours.
First 24 hours
Pruritus
Time Frame: First 24 hours
The incidence of pruritus will be rated on a 10 cm VAS
First 24 hours
Incidente of persistent surgical pain
Time Frame: 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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Thammasat University

Investigators

  • Principal Investigator: Albert Moore, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-5732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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