Analgesia for 2nd Trimester Termination of Pregnancy

NCT ID: NCT01563835

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epidural (PCEA)

bupivacaine, fentanyl

Group Type: ACTIVE_COMPARATOR

bupivacaine, fentanyl

Intervention Type: DRUG

10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.

IV PCA

Intravenous fentanyl patient controlled analgesia

Group Type: ACTIVE_COMPARATOR

fentanyl

Intervention Type: DRUG

fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.

Interventions

bupivacaine, fentanyl

10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.

Intervention Type: DRUG

fentanyl

fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.

Intervention Type: DRUG

Other Intervention Names

bupivacaine: Marcaine; fentanyl: fentanyl citrate; fentanyl citrate

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

12-03

Identifier Type: -

Identifier Source: org_study_id