Analgesia for 2nd Trimester Termination of Pregnancy
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|ClinicalTrials.gov Identifier: NCT01563835|
Recruitment Status : Terminated (Recruitment difficulty)
First Posted : March 27, 2012
Last Update Posted : October 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: bupivacaine, fentanyl Drug: fentanyl||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|