Labor PainNCT02758405
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2
A study testing Bupivacaine, Fentanyl and Infusion pump in people with Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Brief Summary: Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). 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
- Labor Pain
- What is being tested?
- Bupivacaine, Fentanyl and Infusion pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Feb 2017
- 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
- ASA 2 or 3
- Full term (≥ 37 weeks gestation)
- Nulliparous
- Singleton pregnancy, vertex presentation
- Active labor: regular painful contractions occurring at 3-at least every 5 minutes and change in cervix
- Verbal Numerical Pain Score (VNPS) at requesting analgesia > 5 (VNPS 0-10)
- Cervical dilatation ≥2 ≤ 5 cm
Who cannot join
- Refusal to provide written informed consent.
- Any contraindication to epidural anesthesia
- Unintentional dural puncture
- Allergy or hypersensitivity to bupivacaine or fentanyl
- Use of opioids or sedatives within the last 4 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 5 of Bupivacaine 0.125% Plus Fentanyl 2 mcg/ml.
Brief Summary:
Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion, intermittent programmed pushes should be used. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). The investigators are currently using pumps set up with PIEB, in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. The investigators have recently concluded a study at MSH using PIEB where they observed excellent results. However, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same dose of the freezing medication, but using a smaller volume of local anesthetic at a higher concentration. This optimization may also further reduce the amount of medication used by each patient.
The hypothesis of this study is that there is an optimal interval time between PIEB boluses of 30 to 60 minutes at a fixed volume of 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.
Read the detailed description
Studies involving programmed intermittent epidural bolus (PIEB) to date have provided an analgesic regimen that delivered an amount of local anesthetic that was below the patient's requirement per hour, as the studies were done in the context of an association with patient controlled epidural anesthesia (PCEA) as a rescue technique. As a result, PCEA requests were frequent and therefore these studies have not been able to truly understand the pharmacology of the bolus technique in the PIEB regimen, as the PCEA utilized by patients added an extra component to the regimen.
At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Based on previous research done by the investigators, the current epidural regimen consists of 10 ml PIEB at 40 minute intervals, with PCEA boluses of 5 ml and a lock out interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour.
In this study, the investigators will offer patients 5mL PIEBs of bupivacaine 0.125% with fentanyl 2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB regimen that will be effective for our patient population using a higher concentration epidural mixture.
- Conditions
- Labor Pain
- Being tested
- Bupivacaine, Fentanyl, Infusion pump
- Keywords
- Epidural, Labor analgesia, Programmed intermittent epidural bolus
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
0.125% Bupivacaine plus fentanyl 2mcg/ml
FentanylDrug
0.125% Bupivacaine plus fentanyl 2mcg/ml
Infusion pumpDevice
Also called CADD-Solis Ambulatory Infusion Pump
Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
| Study group | Role | What they receive |
|---|---|---|
| 60 minutes | Experimental | The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. Receives: Drug: Bupivacaine; Drug: Fentanyl; Device: Infusion pump |
| 50 minutes | Experimental | The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. Receives: Drug: Bupivacaine; Drug: Fentanyl; Device: Infusion pump |
| 40 minutes | Experimental | The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. Receives: Drug: Bupivacaine; Drug: Fentanyl; Device: Infusion pump |
| 30 minutes | Experimental | The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. Receives: Drug: Bupivacaine; Drug: Fentanyl; Device: Infusion pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate response of the patient, defined as no request for supplemental analgesia
Adequate response of the patient, defined as no request for supplemental analgesia (PCEA bolus or clinician administered bolus) until the completion of the first stage of labor or until 6 hours following initiation of the programmed intermittent epidural bolus (PIEB).
Measured: 6 hours
Secondary outcomes (4)
Sensory block level
Sensory block to ice will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient still does not feel cold sensation as compared to a control site (frontal part of the head)
Measured: 6 hours
Motor block level assessed using Bromage score
Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.
Measured: 6 hours
Hypotension
A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural).
Measured: 6 hours
Pain score
Pain score measured hourly using VNRS (0-10)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT02758405
- Sponsor's protocol ID
- 16-03
- Status last verified
- May 2017
- First submitted
- 29 Apr 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 5 of Bupivacaine 0.125% Plus Fentanyl 2 mcg/ml.
- ClinicalTrials.gov ID
- NCT02758405
- Acronym / sponsor ID
- 16-03
- Conditions
- Labor Pain
- Keywords
- Epidural, Labor analgesia, Programmed intermittent epidural bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 May 2016 (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.
Brief Summary:
Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion, intermittent programmed pushes should be used. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). The investigators are currently using pumps set up with PIEB, in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. The investigators have recently concluded a study at MSH using PIEB where they observed excellent results. However, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same dose of the freezing medication, but using a smaller volume of local anesthetic at a higher concentration. This optimization may also further reduce the amount of medication used by each patient.
The hypothesis of this study is that there is an optimal interval time between PIEB boluses of 30 to 60 minutes at a fixed volume of 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.
Detailed description
Studies involving programmed intermittent epidural bolus (PIEB) to date have provided an analgesic regimen that delivered an amount of local anesthetic that was below the patient's requirement per hour, as the studies were done in the context of an association with patient controlled epidural anesthesia (PCEA) as a rescue technique. As a result, PCEA requests were frequent and therefore these studies have not been able to truly understand the pharmacology of the bolus technique in the PIEB regimen, as the PCEA utilized by patients added an extra component to the regimen.
At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Based on previous research done by the investigators, the current epidural regimen consists of 10 ml PIEB at 40 minute intervals, with PCEA boluses of 5 ml and a lock out interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour.
In this study, the investigators will offer patients 5mL PIEBs of bupivacaine 0.125% with fentanyl 2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB regimen that will be effective for our patient population using a higher concentration epidural mixture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 60 minutes | Experimental | Drug: Bupivacaine, Drug: Fentanyl, Device: Infusion pumpThe infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. |
| 50 minutes | Experimental | Drug: Bupivacaine, Drug: Fentanyl, Device: Infusion pumpThe infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. |
| 40 minutes | Experimental | Drug: Bupivacaine, Drug: Fentanyl, Device: Infusion pumpThe infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. |
| 30 minutes | Experimental | Drug: Bupivacaine, Drug: Fentanyl, Device: Infusion pumpThe infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ASA 2 or 3
- Full term (≥ 37 weeks gestation)
- Nulliparous
- Singleton pregnancy, vertex presentation
- Active labor: regular painful contractions occurring at 3-at least every 5 minutes and change in cervix
Key exclusion criteria (5 listed)
- Refusal to provide written informed consent.
- Any contraindication to epidural anesthesia
- Unintentional dural puncture
- Allergy or hypersensitivity to bupivacaine or fentanyl
- Use of opioids or sedatives within the last 4 hours.
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 |
|---|---|---|
| BupivacaineAlso: Marcaine0.125% Bupivacaine plus fentanyl 2mcg/ml | Drug | 30 minutes, 40 minutes, 50 minutes, 60 minutes |
| Fentanyl0.125% Bupivacaine plus fentanyl 2mcg/ml | Drug | 30 minutes, 40 minutes, 50 minutes, 60 minutes |
| Infusion pumpAlso: CADD-Solis Ambulatory Infusion PumpInfusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA). | Device | 30 minutes, 40 minutes, 50 minutes, 60 minutes |
Primary outcome
Adequate response of the patient, defined as no request for supplemental analgesia
Time frame: 6 hours
Adequate response of the patient, defined as no request for supplemental analgesia (PCEA bolus or clinician administered bolus) until the completion of the first stage of labor or until 6 hours following initiation of the programmed intermittent epidural bolus (PIEB).
4 secondary outcomes
Sensory block level
Time frame: 6 hours
Motor block level assessed using Bromage score
Time frame: 6 hours
Hypotension
Time frame: 6 hours
Pain score
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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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 Infusion pump in people with Labor 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 24 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequate response of the patient, defined as no request for supplemental analgesia (time frame: 6 hours). 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 24 May 2017.