PainNCT01563835
Analgesia for 2nd Trimester Termination of Pregnancy
A study testing bupivacaine, fentanyl and fentanyl in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- bupivacaine, fentanyl and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- interruption of pregnancy between 12 and 23 6/7 weeks
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine, fentanylDrug
Also called bupivacaine: Marcaine, fentanyl: fentanyl citrate
10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
fentanylDrug
Also called fentanyl citrate
fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
| Study group | Role | What they receive |
|---|---|---|
| Epidural (PCEA) | Active comparator | bupivacaine, fentanyl Receives: Drug: bupivacaine, fentanyl |
| IV PCA | Active comparator | Intravenous fentanyl patient controlled analgesia Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 days
Secondary outcomes (5)
Duration of procedure
Duration of procedure from induction to abortion in hours
Measured: 24 hours
Pain score
Visual analog pain score every 30 minutes during procedure
Measured: 24 hours
Narcotic-related complications
Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.
Measured: 24 hours
Epidural-related complications
Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.
Measured: 24 hours
Surgical intervention
Incidence of surgical intervention and any anesthetic required for intervention.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563835
- Sponsor's protocol ID
- 12-03
- Status last verified
- Oct 2014
- First submitted
- 23 Mar 2012
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia
- ClinicalTrials.gov ID
- NCT01563835
- Acronym / sponsor ID
- 12-03
- Conditions
- Pain
- Keywords
- Termination of pregnancy, Epidural, IV PCA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural (PCEA) | Active comparator | Drug: bupivacaine, fentanylbupivacaine, fentanyl |
| IV PCA | Active comparator | Drug: fentanylIntravenous fentanyl patient controlled analgesia |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- interruption of pregnancy between 12 and 23 6/7 weeks
Key exclusion criteria (7 listed)
- documented allergy to fentanyl or bupivacaine
- coagulopathy
- drug or narcotic abuse
- contraindication to neuraxial analgesia
- inability to comply with IVPCA or PCEA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine, fentanylAlso: bupivacaine: Marcaine, fentanyl: fentanyl citrate10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter. | Drug | Epidural (PCEA) |
| fentanylAlso: fentanyl citratefentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout. | Drug | IV PCA |
Primary outcome
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.
5 secondary outcomes
Duration of procedure
Time frame: 24 hours
Pain score
Time frame: 24 hours
Narcotic-related complications
Time frame: 24 hours
Epidural-related complications
Time frame: 24 hours
Surgical intervention
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine, fentanyl and fentanyl in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery - 40 score on discharge (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.