Analgesia for 2nd Trimester Termination of Pregnancy

Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: bupivacaine, fentanyl; Drug: fentanyl

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural (PCEA); bupivacaine, fentanyl	Drug: bupivacaine, fentanyl; 10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.; Other Names: bupivacaine: Marcaine; fentanyl: fentanyl citrate
Active Comparator: IV PCA; Intravenous fentanyl patient controlled analgesia	Drug: fentanyl; fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.; Other Names: fentanyl citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Epidural; IV PCA; Termination of pregnancy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Fentanyl; Bupivacaine; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 12-03