NCT01563835

Analgesia for 2nd Trimester Termination of Pregnancy

Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	bupivacaine, fentanyl	10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
DRUG	fentanyl	fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-03-27
• Last updated: 2014-10-13

Locations

1 site across 1 country: Canada