protocolSection identificationModule nctId: NCT06266767, orgStudyIdInfo id: MRC-01-18-157, briefTitle: Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia, acronym: PIEB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Labor Pain, conditions: Obstetric Pain, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, maskingDescription: 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, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Levobupivacaine and Fentanyl, outcomesModule primaryOutcomes measure: The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Total local anesthetic consumption, secondaryOutcomes measure: Need for supplementary epidural analgesia, secondaryOutcomes measure: Bromage score (lower limb weakness score), secondaryOutcomes measure: Type of delivery, secondaryOutcomes measure: Sensory block, secondaryOutcomes measure: Fetal Outcome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hamad Medical Corporation (HMC), city: Doha, zip: 3050, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, hasResults: False