Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analgesia for 2nd Trimester Termination of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563835
Recruitment Status : Terminated (Recruitment difficulty)
First Posted : March 27, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pain Drug: bupivacaine, fentanyl Drug: fentanyl Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: fentanyl citrate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Quality of Recovery - 40 score on discharge [ Time Frame: 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 :
  1. Duration of procedure [ Time Frame: 24 hours ]
    Duration of procedure from induction to abortion in hours

  2. Pain score [ Time Frame: 24 hours ]
    Visual analog pain score every 30 minutes during procedure

  3. Narcotic-related complications [ Time Frame: 24 hours ]
    Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.

  4. Epidural-related complications [ Time Frame: 24 hours ]
    Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.

  5. Surgical intervention [ Time Frame: 24 hours ]
    Incidence of surgical intervention and any anesthetic required for intervention.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563835


Locations
Layout table for location information
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01563835    
Other Study ID Numbers: 12-03
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Termination of pregnancy
Epidural
IV PCA
Additional relevant MeSH terms:
Layout table for MeSH terms
Fentanyl
Bupivacaine
Citric Acid
Sodium Citrate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
 Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action