Analgesia for 2nd Trimester Termination of Pregnancy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01563835
• Other study ID #: 12-03
• Status: Terminated
• Phase: N/A
• First received: March 23, 2012
• Last updated: October 9, 2014
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• bupivacaine, fentanyl
10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
• fentanyl
fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery - 40 score on discharge	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.	up to 5 days	No
Secondary	Duration of procedure	Duration of procedure from induction to abortion in hours	24 hours	No
Secondary	Pain score	Visual analog pain score every 30 minutes during procedure	24 hours	No
Secondary	Narcotic-related complications	Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.	24 hours	No
Secondary	Epidural-related complications	Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.	24 hours	No
Secondary	Surgical intervention	Incidence of surgical intervention and any anesthetic required for intervention.	24 hours	No