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Dexmedetomidine for Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Epidural analgesia with bupivacaine and dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age 18 - 45 years Scheduled for normal vaginal delivery ASA physical status ӀI-IӀӀ. Singleton non-complicated pregnancy. At least 36 weak of gestation. Vertex presentation. Exclusion Criteria: Patient refusal to epidural analgesia. History of cardiac, liver, or kidney diseases. History of allergy to amide local anesthetics or study medications. Any neurological problem. History of chronic opioid analgesic use. Any contraindication of regional anesthesia. Evidence of intrauterine growth restriction or fetal compromise. Failed or unsatisfactory analgesic block. Body mass index ≥40 kg/m2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group P (PIEB-group)

    Group C (CEI-group)

    Arm Description

    After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

    After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

    Outcomes

    Primary Outcome Measures

    total volume of local anesthetic
    total volume of local anesthetic received through patient controlled epidural analgesia per hour

    Secondary Outcome Measures

    Ramsay sedation scale
    Completely awake or asleep and not responsive to any stimulus
    Heart rate
    Beat per minute
    Blood Pressure
    mmHg
    Likert scale for satisfaction
    very satisfied or very dissatisfied
    Bromage score for motor block
    free movement of legs and feet or unable to move legs and feet

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    March 22, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05781854
    Brief Title
    Dexmedetomidine for Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia
    Official Title
    Dexmedetomidine for Programed Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia: A Randomized Controlled Double-blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare two modes of labour epidural analgesia: programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour
    Detailed Description
    Labour although varies with the individual may be the most painful experience, any women may ever encounter. Concerns about pain in labour are as old as mankind. Pain can make patients feel uncomfortable and become sleepless and agitated. Pain also stimulates the sympathetic nervous system, which causes increase in the heart rate, blood pressure, sweat production, endocrine hyper-function, and delays the patients' prognosis. Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased. The ideal labor analgesia should be based on maternal and child safety and should have a fast-acting good analgesic effect and less adverse reaction. Different adjuvants such as opioids and α2-adrenergic agonists were added to local anesthetics to improve the quality of intraoperative and postoperative analgesia. Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia . Dexmedetomidine have several beneficial actions during perioperative period. It decreases the sympathetic tone with attenuation of the neuroendocrine and hemodynamic response to anesthesia and surgery, reduce anesthetic and opioid requirement, cause sedation and analgesia. Dexmedetomidine was used to enhance the analgesic property of local anesthetics like lidocaine, bupivacaine and ropivacaine. The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2-adrenergic agonist. Maintenance of epidural analgesia involved intermittent provider , administered boluses, patient-controlled epidural analgesia, and continuous epidural infusions with or without patient-controlled epidural analgesia. Continuous epidural infusion is the standard application setting for epidural infusion, highly effective, and provides consistent analgesia. however, is associated with greater local anesthetic consumption . A newer approach to maintenance of labor epidural analgesia involves the administration of programmed intermittent epidural boluses with patient-controlled epidural analgesia dosing for breakthrough pain. Earlier studies have suggested that programmed intermittent epidural boluses may be superior to continuous epidural infusion for labor analgesia and may be associated with a reduction in local anesthetic requirement, decreased motor blockade, lower risk of instrumental deliveries, and improved patient satisfaction. This may be related to increased pressure generated during automated boluses, resulting in improved distribution of the local anesthetic in the epidural space .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group P (PIEB-group)
    Arm Type
    Active Comparator
    Arm Description
    After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).
    Arm Title
    Group C (CEI-group)
    Arm Type
    Active Comparator
    Arm Description
    After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).
    Intervention Type
    Drug
    Intervention Name(s)
    Epidural analgesia with bupivacaine and dexmedetomidine
    Intervention Description
    Epidural analgesia with bupivacaine and dexmedetomidine
    Primary Outcome Measure Information:
    Title
    total volume of local anesthetic
    Description
    total volume of local anesthetic received through patient controlled epidural analgesia per hour
    Time Frame
    24 hour
    Secondary Outcome Measure Information:
    Title
    Ramsay sedation scale
    Description
    Completely awake or asleep and not responsive to any stimulus
    Time Frame
    24 hour
    Title
    Heart rate
    Description
    Beat per minute
    Time Frame
    24 hour
    Title
    Blood Pressure
    Description
    mmHg
    Time Frame
    24 hour
    Title
    Likert scale for satisfaction
    Description
    very satisfied or very dissatisfied
    Time Frame
    24 hour
    Title
    Bromage score for motor block
    Description
    free movement of legs and feet or unable to move legs and feet
    Time Frame
    24 hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 - 45 years Scheduled for normal vaginal delivery ASA physical status ӀI-IӀӀ. Singleton non-complicated pregnancy. At least 36 weak of gestation. Vertex presentation. Exclusion Criteria: Patient refusal to epidural analgesia. History of cardiac, liver, or kidney diseases. History of allergy to amide local anesthetics or study medications. Any neurological problem. History of chronic opioid analgesic use. Any contraindication of regional anesthesia. Evidence of intrauterine growth restriction or fetal compromise. Failed or unsatisfactory analgesic block. Body mass index ≥40 kg/m2
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hassan Khaled Ahmed Gomaa, Resident
    Phone
    01067319365
    Email
    hassssan.khaled2013@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Fathy Mostafa, Ass. Prof.
    Phone
    01001123062
    Email
    mo7_fathy@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zein El-Abden Zareh Hassan, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    Ebirim, L.N., Buowari, O.Y., Ghosh, S. Physical and Psychological Aspects of Pain in Obstetrics. In: Ghosh, S., editor. Pain in Perspective [Internet]. London: IntechOpen; 2012 [cited 2022 Oct 18]. Available from: https://www.intechopen.com/chapters/40395 doi: 10.5772/53923
    Results Reference
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    Citation
    Fortescue C, Wee MYK. Analgesia in labour: non-regional techniques. Continuing Education in Anaesthesia, Critical Care, and Pain. 2005; 5(1): 219-223.
    Results Reference
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    PubMed Identifier
    32333825
    Citation
    Paramasivan A, Lopez-Olivo MA, Foong TW, Tan YW, Yap APA. Intrathecal dexmedetomidine and postoperative pain: A systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020 Aug;24(7):1215-1227. doi: 10.1002/ejp.1575. Epub 2020 May 22.
    Results Reference
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    Citation
    Verghese T, Dixit N, John L, et al. Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine - A comparative study. Indian J Clin Anaesth. 2019;6(1):97-101
    Results Reference
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    PubMed Identifier
    31461801
    Citation
    Mostafa MF, Herdan R, Fathy GM, Hassan ZEAZ, Galal H, Talaat A, Ibrahim AK. Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study. Eur J Pain. 2020 Jan;24(1):182-191. doi: 10.1002/ejp.1476. Epub 2019 Sep 12.
    Results Reference
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    PubMed Identifier
    15189665
    Citation
    Martin E, Ramsay G, Mantz J, Sum-Ping ST. The role of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedation in the intensive care unit. J Intensive Care Med. 2003 Jan-Feb;18(1):29-41. doi: 10.1177/0885066602239122.
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    PubMed Identifier
    16369581
    Citation
    Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
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    PubMed Identifier
    19700777
    Citation
    Werdehausen R, Fazeli S, Braun S, Hermanns H, Essmann F, Hollmann MW, Bauer I, Stevens MF. Apoptosis induction by different local anaesthetics in a neuroblastoma cell line. Br J Anaesth. 2009 Nov;103(5):711-8. doi: 10.1093/bja/aep236. Epub 2009 Aug 22.
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    Fairbanks CA, Wilcox GL. Spinal antinociceptive synergism between morphine and clonidine persists in mice made acutely or chronically tolerant to morphine. J Pharmacol Exp Ther. 1999 Mar;288(3):1107-16.
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    PubMed Identifier
    28625301
    Citation
    Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
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    Ojo OA, Mehdiratta JE, Gamez BH, Hunting J, Habib AS. Comparison of Programmed Intermittent Epidural Boluses With Continuous Epidural Infusion for the Maintenance of Labor Analgesia: A Randomized, Controlled, Double-Blind Study. Anesth Analg. 2020 Feb;130(2):426-435. doi: 10.1213/ANE.0000000000004104.
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    El Fawal, S., El Kabarity, R., Ahmed, N., Abd-El-Tawab, S. (2022). Effect of Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia. A randomized clinical trial. Egyptian J Anesthesia: 38 (1); 373382
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    Dexmedetomidine for Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia

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