Analgesia for 2nd Trimester Termination of Pregnancy

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Drug: bupivacaine, fentanyl; Drug: fentanyl

• Registration Number: NCT01563835
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Detailed Description

Epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. This mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances.

We plan to compare patient controlled epidural analgesia (PCEA) with intravenous patient controlled analgesia (IV PCA), for 2nd trimester terminations of pregnancy. We hypothesize that PCEA provides better quality of recovery than IV PCA. The previously validated Quality of Recovery - 40 questionnaire will be used to measure a patient's quality of recovery. The results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• interruption of pregnancy between 12 and 23 6/7 weeks

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural (PCEA)	bupivacaine, fentanyl	bupivacaine, fentanyl
IV PCA	fentanyl	Intravenous fentanyl patient controlled analgesia

Primary Outcome Measures

Name	Time	Method
Quality of Recovery - 40 score on discharge	up to 5 days	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.

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	24 hours	Duration of procedure from induction to abortion in hours
Pain score	24 hours	Visual analog pain score every 30 minutes during procedure
Narcotic-related complications	24 hours	Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.
Epidural-related complications	24 hours	Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.
Surgical intervention	24 hours	Incidence of surgical intervention and any anesthetic required for intervention.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada