- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266767
Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia (PIEB)
Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia; Finding the Optimum Combination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many women experience severe pain during labour. There are many forms of pain relief methods available to women in developed countries. Labour epidural analgesia remains the most effective form of pain relief. It is also the least depressive to the central nervous system of the mother and the baby. After initiating epidural analgesia, there are many regimens that can be employed to maintain analgesia for the duration of labour.
Traditionally, epidural analgesia (using low dose mixtures of local anaesthetic and opioid) has been administered by nurse or midwife-controlled manual boluses or as continuous infusion via a dedicated epidural pump (once the epidural catheter has been placed by an anaesthetist). Although these regimens provide an effective form of labour analgesia, patient satisfaction is not always achieved because of the associated lower limb motor block (leg weakness) and the increased risk of requiring instrumental delivery such as a forceps delivery. Due to recent advances in medical technology, new epidural pumps, which allow patient controlled epidural analgesia (PCEA) boluses and programmed intermittent epidural (PIEB) boluses, are now available.
Bolus injection through an epidural catheter may result in better distribution of anaesthetic solution in the epidural space when compared with continuous infusion of the same low dose local anaesthetic / opioid mixture. Capogna et al carried out a randomized double-blind study to compare the effects of a programmed intermittent epidural bolus (PIEB) regimen with a continuous epidural infusion (CEI). Motor block was reported in 37% in the CEI group and in only 2.7% in the PIEB group (P < 0.001). The incidence of instrumental delivery was 20% for the CEI group and 7% for the PIEB group (P = 0.03). The total local anaesthetic consumption, number of patients requiring additional PCEA boluses, and mean number of PCEA boluses per patient were also found to be lower in the PIEB group (P < 0.001). There were no differences in pain scores and duration of labour analgesia. (Capogna et al, 2011) Another randomized controlled study published by Wong et al compared total local anaesthetic (bupivacaine was used in this study) consumption, need for supplemental epidural analgesia, quality of analgesia, and patient satisfaction in women who received programmed intermittent epidural boluses (PIEB) compared with continuous epidural infusion (CEI) for maintenance of labour epidural analgesia. The median total bupivacaine dose per hour of analgesia was significantly less in the PIEB (n = 63) (10.5 mg/h; 95% confidence interval, 9.5-11.8 mg/h) when compared with the CEI group (n = 63) (12.3 mg/h; 95% confidence interval, 10.5-14.0 mg/h) (P < 0.01). Patient satisfaction scores were also higher in the PIEB group. The authors concluded that PIEB combined with patient controlled epidural analgesia (PCEA) provided similar analgesia, but with a smaller bupivacaine dose and better patient satisfaction compared with CEI with PCEA for maintenance of epidural labour analgesia. (Wong et al, 2006) Wong et al carried out another study to evaluate bupivacaine consumption and other analgesic outcomes when the programmed intermittent bolus time interval and volume were manipulated during the maintenance of epidural labour analgesia. They found that extending the programmed intermittent bolus interval and volume from 15 minutes to 60 minutes, and 2.5 mL to 10 mL, respectively, decreased bupivacaine consumption without decreasing patient comfort or satisfaction. (Wong et al, 2011) In our study, we aim to compare the effects of different combinations of PIEB bolus volume and PIEB time interval on the number of PCEA demands / clinician boluses, pain score, local anaesthetic consumption and patient satisfaction in order to find the optimal PIEB volume and PIEB time interval for labour pain relief when used together with a fixed (pre-determined) PCEA regimen.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Roshan Fernando, MD
- Phone Number: 0097444392219
- Email: RFernando1@hamad.qa
Study Contact Backup
- Name: Mitko Kocarev, MD
- Phone Number: 0097444392219
- Email: MKocarev@hamad.qa
Study Locations
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-
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Doha, Qatar, 3050
- Hamad Medical Corporation (HMC)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 50 yrs
- In active labour
- ASA 2 patients (pregnant patients are considered to be ASA 2)
- Singleton pregnancy
- > 37 weeks gestation
- Booking BMI 18 to 35
Exclusion Criteria:
- BMI < 18
- BMI > 35
- Systemic opioids within the previous 6 hours
- Presence of a fetal anomaly
- Pre-eclampsia
- Bleeding disorders (including coagulation disorders)
- Recent spinal surgery
- Spinal injury
- Elevated intracranial pressure (ICP)
- Neuraxial disorders of any description
- Signs of local or systemic infection
- Patient refusal for neuraxial analgesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
PIEB bolus vol (ml) : 8 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 2
PIEB bolus vol (ml) : 8 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 3
PIEB bolus vol (ml) : 10 PIEB time interval (min) : 30 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 4
PIEB bolus vol (ml) : 10 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 5
PIEB bolus vol (ml) : 10 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 6
PIEB bolus vol (ml) : 10 PIEB time interval (min) : 75 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 7
PIEB bolus vol (ml) : 12 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
Experimental: Group 8
PIEB bolus vol (ml) : 12 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20
|
Programmed Intermittent Epidural Bolus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
The (composite) primary outcome will identify the 2 best performing groups
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From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Numeric Rating Scale (NRS).
Patient self-reported pain scale.
0 (No Pain) to 10 (Worst possible pain)
|
From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Total local anesthetic consumption
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Initial Epidural Bolus + Total volume PIEB + Total volume PCEA + Clinician bolus volume
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From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Need for supplementary epidural analgesia
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Total volume PCEA + Total volume clinician Bolus
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From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Bromage score (lower limb weakness score)
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Bromage Score -1: Free movement of legs and feet, 2: Just able to flex knees, able to move feet, 3: Unable to flex knees, able to move feet, 4 :Unable to move legs or feet
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From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
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Type of delivery
Time Frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Normal vaginal delivery, cesarean delivery, forceps and vacuum delivery
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From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
|
Sensory block
Time Frame: From the siting of the epidural block for 3 hours
|
Assessed with cold spray (ethyl chloride)
|
From the siting of the epidural block for 3 hours
|
Fetal Outcome
Time Frame: At the time of birth and 5 minutes after delivery
|
Umbilical cord blood gases + Apgar scores
|
At the time of birth and 5 minutes after delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Levobupivacaine
Other Study ID Numbers
- MRC-01-18-157
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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