- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887222
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor-3
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 ml of Bupivacaine 0.125% Plus Fentanyl 2 mcg/ml
Until recently, at Mount Sinai Hospital (MSH), 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 we should use intermittent programmed pushes. 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). Recently the epidural pumps at MSH were reprogrammed to deliver bolus of medication at regular intervals (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 excellent results were observed. However, in that study, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same interval of the previous study with smaller volumes of the intermittent boluses. Optimizing the technique, may allow the investigators to be able to reduce even further the amount of medication used by each patient.
The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of women the necessary drug requirements during first stage of labor (EV90), thus avoiding breakthrough pain and need for PCEA or physician intervention. We hypothesize that this effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).
Study Overview
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 vary the volume of the bolus (7-12 mL) of bupivacaine 0.0625% with fentanyl 2mcg/ml. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB volume that will be effective for our patient population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA 2 or 3
- ≥ 37 weeks gestation
- nulliparous
- Singleton pregnancy, vertex presentation
- Active labor: regular painful contractions occurring at 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
Exclusion Criteria:
- Refusal to provide written informed consent
- Patients unable to communicate fluently in English
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: PIEB volume of 7 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 7mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: PIEB volume of 8 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 8mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: PIEB volume of 9 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 9mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: PIEB volume of 10 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: PIEB volume of 11 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 11mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: PIEB volume of 12 mL
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 12mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
|
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor block level assessed using Bromage score
Time Frame: 6 hours
|
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.
|
6 hours
|
Pain score
Time Frame: 6 hours
|
Pain score measured hourly using VNRS (0-10)
|
6 hours
|
Hypotension
Time Frame: 6 hours
|
A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural).
|
6 hours
|
Sensory block level to ice
Time Frame: 6 hours
|
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 normal cold sensation as compared to a control site (lateral upper arm).
|
6 hours
|
Sensory block level to pin prick
Time Frame: 6 hours
|
Sensory block to pin prick will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient initial begins to feel normal sharp sensation compared to a control site (lateral upper arm).
|
6 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Labor Pain
-
Cukurova UniversityRecruitingLabor Pain, Labor Perception, Hormone Levels and Childbirth ComfortTurkey
-
Soovu Labs Inc.Virginia Mason Hospital/Medical CenterNot yet recruiting
-
Bogomolets National Medical UniversityCompleted
-
Martin-Luther-Universität Halle-WittenbergRecruiting
-
Maimonides Medical CenterTerminated
-
Aretaieio HospitalRecruitingLabor Pain | Pain, Labor | EpiduralGreece
-
Mashhad University of Medical SciencesTerminatedDecrease Labor Pain
-
Amasya UniversityAtaturk UniversityNot yet recruitingSatisfaction, Patient | Pain, Labor
-
University Medical Centre LjubljanaCompletedLabor Pain | Labor; Prolonged, First Stage | Labor; Prolonged, Second StageSlovenia
Clinical Trials on Bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
DurectNycomedCompletedPostoperative PainAustria, Germany, Latvia, Poland, Sweden
-
DurectNycomedCompletedPostoperative PainFrance, Germany, Hungary, Latvia, Sweden, United Kingdom
-
Indiana UniversityCompletedPain, Postoperative | Acute Pain | ThoracicUnited States
-
Vanderbilt University Medical CenterCompletedAnesthesia | Breast Reconstruction | Transverse Abdominis Plane BlockUnited States
-
Seoul National University HospitalUnknownAnesthesia, Spinal [E03.155.086.331] | Operating Tables [E07.325.662]Korea, Republic of
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro SocialCompletedObstetric PainMexico
-
Indiana UniversityCompleted
-
University of Texas Southwestern Medical CenterCompleted