Analgesia for 2nd Trimester Termination of Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01563835
First received: March 23, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pain
Drug: bupivacaine, fentanyl
Drug: fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Quality of Recovery - 40 score on discharge [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    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:
  • Duration of procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Duration of procedure from induction to abortion in hours

  • Pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Visual analog pain score every 30 minutes during procedure

  • Narcotic-related complications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.

  • Epidural-related complications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.

  • Surgical intervention [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Incidence of surgical intervention and any anesthetic required for intervention.


Estimated Enrollment: 92
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: fentanyl citrate

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.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563835

Contacts
Contact: Jose CA Carvalho, MD 416-586-4800 ext 2681 jose.carvalho@uhn.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Jose CA Carvalho, MD    416-586-4800 ext 2681    jose.carvalho@uhn.ca   
Principal Investigator: Jose CA Carvalho, MD         
Sub-Investigator: Tamara Henderson, MD         
Sub-Investigator: Naveed Siddiqui, MD         
Sub-Investigator: James Teresi, MD         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01563835     History of Changes
Other Study ID Numbers: 12-03
Study First Received: March 23, 2012
Last Updated: January 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Termination of pregnancy
Epidural
IV PCA

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014