Study Stopped
Recruitment difficulty
Analgesia for 2nd Trimester Termination of Pregnancy
1 other identifier
interventional
42
1 country
1
Brief Summary
There has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. The standard of practice in North America is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as fentanyl. The goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard of care for live births. The study will be conducted as a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Mar 2012
Typical duration for not_applicable pain
1 active site
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
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 13, 2014
October 1, 2014
1.8 years
March 23, 2012
October 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Recovery - 40 score on discharge
The primary outcome of this study will be the difference between IV PCA and PCEA groups in aggregate score of Quality of Recovery - 40 on discharge from hospital.
up to 5 days
Secondary Outcomes (5)
Duration of procedure
24 hours
Pain score
24 hours
Narcotic-related complications
24 hours
Epidural-related complications
24 hours
Surgical intervention
24 hours
Study Arms (2)
Epidural (PCEA)
ACTIVE COMPARATORbupivacaine, fentanyl
IV PCA
ACTIVE COMPARATORIntravenous fentanyl patient controlled analgesia
Interventions
10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
Eligibility Criteria
You may qualify if:
- interruption of pregnancy between 12 and 23 6/7 weeks
You may not qualify if:
- documented allergy to fentanyl or bupivacaine
- coagulopathy
- drug or narcotic abuse
- contraindication to neuraxial analgesia
- inability to comply with IVPCA or PCEA
- inability to complete the QoR-40 questionnaire
- TOP due to maternal problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose CA Carvalho, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 27, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
October 13, 2014
Record last verified: 2014-10