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Analgesic Additives to Epidural Bupivacaine in Normal Labor

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
fentanyl
Nalbuphine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring epidural anathesia, normal labor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: >/= 18 years of age American Society of Anesthesiologists (ASA) Physical Status 2 or 3 Full term pregnancy (>37 gestational weeks) Planning vaginal delivery Planning epidural labor analgesia Vertex presentation Exclusion Criteria: Patient refusal to epidural analgesia, Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity) Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine) hemodynamic instability, severe aortic or mitral stenosis) Severe pre-eclampsia, Breech presentations Antepartum hemorrhage Cephalopelvic disproportion Body mass index ≥40 kg/m2. Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac] Known or suspected fetal abnormalities Inability to communicate or participate in study procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    epidural Bupivacaine with Dexmedetomidine in normal labor

    epidural Bupivacaine with fentanyl in normal labor

    epidural Bupivacaine with Nalbuphine in normal labor

    Arm Description

    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml

    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.

    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.

    Outcomes

    Primary Outcome Measures

    VAS score for pain
    changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2023
    Last Updated
    February 16, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05746351
    Brief Title
    Analgesic Additives to Epidural Bupivacaine in Normal Labor
    Official Title
    Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    July 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 the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.
    Detailed Description
    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 . Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. 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 . Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia . Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics. Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings . It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension . Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses . The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain
    Keywords
    epidural anathesia, normal labor

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    epidural Bupivacaine with Dexmedetomidine in normal labor
    Arm Type
    Active Comparator
    Arm Description
    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml
    Arm Title
    epidural Bupivacaine with fentanyl in normal labor
    Arm Type
    Active Comparator
    Arm Description
    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.
    Arm Title
    epidural Bupivacaine with Nalbuphine in normal labor
    Arm Type
    Active Comparator
    Arm Description
    Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    precedex
    Intervention Description
    a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Other Intervention Name(s)
    Durogesic
    Intervention Description
    a group will receive epidural Bupivacaine with fentanyl in normal labor
    Intervention Type
    Drug
    Intervention Name(s)
    Nalbuphine
    Other Intervention Name(s)
    Nalufin
    Intervention Description
    a group will receive epidural Bupivacaine with Nalbuphine in normal labor
    Primary Outcome Measure Information:
    Title
    VAS score for pain
    Description
    changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
    Time Frame
    before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: >/= 18 years of age American Society of Anesthesiologists (ASA) Physical Status 2 or 3 Full term pregnancy (>37 gestational weeks) Planning vaginal delivery Planning epidural labor analgesia Vertex presentation Exclusion Criteria: Patient refusal to epidural analgesia, Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity) Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine) hemodynamic instability, severe aortic or mitral stenosis) Severe pre-eclampsia, Breech presentations Antepartum hemorrhage Cephalopelvic disproportion Body mass index ≥40 kg/m2. Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac] Known or suspected fetal abnormalities Inability to communicate or participate in study procedures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abanob Fathy Zareef, MBBS
    Phone
    01010424707
    Email
    bebofathy47@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zein EA Zareh Hassan, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Elwani Eldramy Elsenosi, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Khaled Tolba Younes, Lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/32333825/
    Description
    Paramasivan A, Lopez-Olivo MA, Foong TW, et al. Intrathecal dexmedetomidine and postoperative pain: a systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020;24(7):1215-1227
    URL
    https://www.ijca.in/journal-article-file/8541
    Description
    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.
    URL
    https://innovareacademics.in/journals/index.php/ajpcr/article/view/26096
    Description
    Senapati LK, Samanta P. Effect of intravenous versus intrathecal dexmedetomidine on characteristics of hyperbaric bupivacaine spinal anesthesia in lower limb surgery. Asian J Pharm Clin Res. 2018;11:427-430.
    URL
    https://pubmed.ncbi.nlm.nih.gov/27746540/
    Description
    Santpur MU, Kahalekar GM, Saraf N, et al. Effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: a prospective randomized control study. Anesth Essays Res. 2016;10(3):497-501.
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6493572/
    Description
    ] Niu XY, Ding XB, Guo T, et al. Effects of intravenous and intrathecal dexmedetomidine in spinal anesthesia: a meta-analysis. CNS Neurosci Ther. 2013;19(11):897-904.
    URL
    https://pubmed.ncbi.nlm.nih.gov/1914055/
    Description
    Camann WR, Hurley RH, Gilbertson LI, et al. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991;38(6):728-732.
    URL
    https://pubmed.ncbi.nlm.nih.gov/26712968/
    Description
    ] Chatrath V, Attri JP, Bala A, et al. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015;9(3):326.

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    Analgesic Additives to Epidural Bupivacaine in Normal Labor

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