Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia

NCT06266767 | Completed Phase 4 DMC

• 1 other identifier: MRC-01-18-157
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score.

Conditions

Labor Pain; Obstetric Pain; Analgesia

Keywords

Obstetrics; Analgesia; Epidural; Patient-Controlled; Opioid

Outcome Measures

Primary Outcomes (1)

• The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score

  The (composite) primary outcome will identify the 2 best performing groups

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

Secondary Outcomes (7)

• Pain score

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

• Total local anesthetic consumption

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

• Need for supplementary epidural analgesia

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

• Bromage score (lower limb weakness score)

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

• Type of delivery

  From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

Study Arms (8)

Group 1

EXPERIMENTAL

PIEB bolus vol (ml) : 8 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 2

EXPERIMENTAL

PIEB bolus vol (ml) : 8 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 3

EXPERIMENTAL

PIEB bolus vol (ml) : 10 PIEB time interval (min) : 30 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 4

EXPERIMENTAL

PIEB bolus vol (ml) : 10 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 5

EXPERIMENTAL

PIEB bolus vol (ml) : 10 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 6

EXPERIMENTAL

PIEB bolus vol (ml) : 10 PIEB time interval (min) : 75 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 7

EXPERIMENTAL

PIEB bolus vol (ml) : 12 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Group 8

EXPERIMENTAL

PIEB bolus vol (ml) : 12 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20

Drug: Levobupivacaine and Fentanyl

Interventions

Levobupivacaine and Fentanyl DRUG

Programmed Intermittent Epidural Bolus

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7; Group 8

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: parturient 37+ weeks
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation (HMC)

Doha, Baladīyat ad Dawḩah, 3050, Qatar

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Levobupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roshan Fernando, MD

  Hamad Medical Corporation, Qatar

  PRINCIPAL INVESTIGATOR

• Fatima Khatoon, DESAIC

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a randomized double-blinded design. Patients and their attending physicians / clinical anaesthetists / data collection study member / midwives / nurses will be blinded to patient group allocation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups. There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups.

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: February 20, 2024
• Study Start: February 21, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

QA (1)