NCT04256642

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

January 30, 2020

Last Update Submit

February 3, 2020

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Measurement of quality of recovery after cesarean delivery

    First 24 hours

  • Nausea and vomiting

    First 24 hours

  • Analgesic usage

    First 24 hours

  • Pruritus

    First 24 hours

  • Incidente of persistent surgical pain

    Three months

Study Arms (2)

Intrathecal morphine

ACTIVE COMPARATOR
Drug: Intrathecal morphine

Erector Spinae Plane Block

EXPERIMENTAL
Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane BlockPROCEDURE

A nerve block that injects local anesthetic in the Erector Spinae Plane

Erector Spinae Plane Block
Intrathecal morphineDRUG

Intrathecal morphine at the time of spinal anesthesia

Intrathecal morphine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing scheduled Cesarean delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, Canada

RECRUITING

Study Officials

  • Albert Moore, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Moore, MD

CONTACT

5149341934albert.moore@mcgill.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)