Pain
Conditions
Keywords
Termination of pregnancy, Epidural, IV PCA
Brief 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.
Interventions
10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
DRUGfentanyl
fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
Sponsors
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery - 40 score on discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of procedure | 24 hours | Duration of procedure from induction to abortion in hours |
| Pain score | 24 hours | Visual analog pain score every 30 minutes during procedure |
| Narcotic-related complications | 24 hours | Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression. |
| Epidural-related complications | 24 hours | Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications. |
| Surgical intervention | 24 hours | Incidence of surgical intervention and any anesthetic required for intervention. |
Countries
Canada
Outcome results
None listed