Analgesia for 2nd Trimester Termination of Pregnancy
|Study Design:||Allocation: Randomized
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 ]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 ]Duration of procedure from induction to abortion in hours
- Pain score [ Time Frame: 24 hours ]Visual analog pain score every 30 minutes during procedure
- Narcotic-related complications [ Time Frame: 24 hours ]Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.
- Epidural-related complications [ Time Frame: 24 hours ]Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.
- Surgical intervention [ Time Frame: 24 hours ]Incidence of surgical intervention and any anesthetic required for intervention.
|Study Start Date:||March 2012|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 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
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|