Back to resultsA Comparison of Epidural Techniques for Labour Analgesia
Primary Purpose
Labour Analgesia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Labour Analgesia
Eligibility Criteria
Inclusion Criteria:
- Healthy, singleton presentation at term
Exclusion Criteria:
- Significant comorbidities likely to alter outcome of labour
Sites / Locations
- BC Women's Hospital
- British Columbia's Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Epidural Technique
Combined Spinal Epidural Technique
Arm Description
Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.
CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.
Outcomes
Primary Outcome Measures
Bupivacaine requirement for analgesia
milligram of bupivacaine used per hour
Secondary Outcome Measures
Full Information
NCT ID
NCT03065569
First Posted
January 19, 2017
Last Updated
May 23, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03065569
Brief Title
A Comparison of Epidural Techniques for Labour Analgesia
Official Title
A Comparison of Epidural Techniques for Labour Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 7, 2017 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
May 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A trial comparing outcomes for different epidural techniques in labour analgesia
Detailed Description
Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labour Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Epidural Technique
Arm Type
Active Comparator
Arm Description
Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.
Arm Title
Combined Spinal Epidural Technique
Arm Type
Experimental
Arm Description
CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
16 mL of 0.125% bupivacaine
Primary Outcome Measure Information:
Title
Bupivacaine requirement for analgesia
Description
milligram of bupivacaine used per hour
Time Frame
From randomization until delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, singleton presentation at term
Exclusion Criteria:
Significant comorbidities likely to alter outcome of labour
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Chau, MD MMSc
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
British Columbia's Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of Epidural Techniques for Labour Analgesia
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