Analgesia for 2nd Trimester Termination of Pregnancy

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Terminated

Conditions: Pain

Treatments: Drug: fentanyl; Drug: bupivacaine, fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01563835

12-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Epidural (PCEA)

Active Comparator group

Description:

bupivacaine, fentanyl

Treatment:

Drug: bupivacaine, fentanyl

IV PCA

Active Comparator group

Description:

Intravenous fentanyl patient controlled analgesia

Treatment:

Drug: fentanyl