Analgesia for 2nd Trimester Termination of Pregnancy
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 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|
- 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.
- 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.
|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)|
Active Comparator: Epidural (PCEA)
Drug: bupivacaine, fentanyl
10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
Active Comparator: IV PCA
Intravenous fentanyl patient controlled analgesia
fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
Other Name: fentanyl citrate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563835
|Contact: Jose CA Carvalho, MD||416-586-4800 ext email@example.com|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G1X5|
|Contact: Jose CA Carvalho, MD 416-586-4800 ext 2681 firstname.lastname@example.org|
|Principal Investigator: Jose CA Carvalho, MD|
|Sub-Investigator: Tamara Henderson, MD|
|Sub-Investigator: Naveed Siddiqui, MD|
|Sub-Investigator: James Teresi, MD|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|