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Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Clonidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age: ranges from 20 - 35 years old. ASA physical status II. Singleton fetus at term. Parturient scheduled for elective lower segment cesarian section under spinal anethesia Exclusion Criteria: Patient refusal. Contraindications to spinal blockade, such cardiorespiratory problems, coagulopathy, neurological disease, psychological troubles, and allergy to the used drugs. Morbid obesity. Failure of spinal blockade. Emergency CS. Complicated pregnancy. Intrauterine fetal compromise.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group B

    Group BC

    Group BN

    Arm Description

    control group : will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing 1 ml of Dextrose 5%.

    will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Clonidine (30 µg) diluted in Dextrose 5% to a total volume of 1 ml.

    will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Neostigmine (10 µg) diluted in Dextrose 5% to a total volume of 1 ml.

    Outcomes

    Primary Outcome Measures

    postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.
    using numerical rating scale (NRS) pain score that ranges from 0 indicating no pain up to 10 indicating the worst pain

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2023
    Last Updated
    July 5, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05943613
    Brief Title
    Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section
    Official Title
    Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section: A Randomized Double Blind Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 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 delivery of the infant into the arms of a conscious and pain free mother is one of the most exciting and rewarding moments in medicine. Neuraxial anesthesia is now the preferred technique for lower segment cesarean sections (LSCS). Although epidural, spinal, continuous spinal, and combined spinal-epidural techniques have all been advocated, most cesarean sections are performed under single-shot spinal anesthesia. Even when a long acting local anesthetic like bupivacaine is used, the duration of spinal anesthesia (SA) is short and higher doses of analgesics are required in the postoperative period. Therefore, achieving a subarachnoid block that provides high quality postoperative analgesia of consistently prolonged duration is an attractive goal.
    Detailed Description
    Opioids such as morphine, fentanyl, and sufentanil have been administered intrathecally as adjuvants to increase the duration of postoperative analgesia. Although they ensure superior quality of analgesia, they are associated with many side effects such as pruritus, nausea, vomiting, urinary retention, and especially late and unpredictable respiratory depression. This has directed the research toward the use of newer and better local anesthetic additives for SA such as neostigmine, ketamine, midazolam, and clonidine. Neostigmine is an anticholinesterase agent which increases the acetylcholine (Ach) concentration at the cholinergic synapse by blocking the activity of true and pseudocholinesterase enzymes. In postoperative period descending noradrenergic or cholinergic antinociceptive spinal system is activated by ongoing pain causing an increase in the release of Ach, which in the presence of neostigmine results in augmented analgesia. It has no untoward side effects such as respiratory depression, pruritus, and drowsiness as experienced with intrathecal narcotics.Clonidine is an α2-receptor agonist which has gained popularity in recent times as an adjuvant in spinal anesthesia. Analgesic effect of clonidine mediated by α2-adrenoceptors situated in the dorsal horn of spinal cord. The antinociceptive properties of clonidine indicate that it might be useful as an alternative to intrathecal opioids for postoperative analgesia, thus also avoiding the adverse effect of opioids. Neostigmine was used in different dose ranges from 5 µg to 750 µg intrathecally but a low dose of 5 µg is sufficient to cause early onset of sensory and motor block. On the other hand, clonidine was used in different doses from 15 µg to 450 µg, and many previous studies concluded that minimum 30 µg dose of clonidine provide a significant increase in the duration of sensory block, motor block, and spinal analgesia without increasing the incidence of side effects. Dextrose 5% is used to make the adjuvant solutions more hyperbaric because in some studies, when hyperbaric solution of neostigmine was used, the incidence of nausea and vomiting was reduced by preventing cephalic spread of the drug to the brain stem. Stress responses to surgical trauma and postoperative pain elicit diffuse changes in hormonal secretion such as adrenocorticotropic hormone (ACTH), cortisol and prolactin, with several deleterious metabolic and cardiovascular effects that can be prevented by effective postoperative analgesia. Cortisol is a key player in the stress response and its secretion is facilitated by the ACTH which interacts with the sympathetic nervous system and the inhibitory control of endogenous opioid peptides, influencing pain processing.(12) Negative associations between cortisol levels and subsequent pain perception suggest the possibility that the hypothalamic-pituitary- adrenal (HPA) axis contributes to attenuating pain perception during acute stressful events, possibly mediated by increased cortisol.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    111 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group B
    Arm Type
    Placebo Comparator
    Arm Description
    control group : will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing 1 ml of Dextrose 5%.
    Arm Title
    Group BC
    Arm Type
    Active Comparator
    Arm Description
    will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Clonidine (30 µg) diluted in Dextrose 5% to a total volume of 1 ml.
    Arm Title
    Group BN
    Arm Type
    Active Comparator
    Arm Description
    will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Neostigmine (10 µg) diluted in Dextrose 5% to a total volume of 1 ml.
    Intervention Type
    Drug
    Intervention Name(s)
    Clonidine
    Intervention Description
    compare the effect of intrathecal Clonidine and Neostigmine as adjuvants to Bupivacaine in elective cesarean section
    Primary Outcome Measure Information:
    Title
    postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.
    Description
    using numerical rating scale (NRS) pain score that ranges from 0 indicating no pain up to 10 indicating the worst pain
    Time Frame
    2 hours after time of sensory block

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: ranges from 20 - 35 years old. ASA physical status II. Singleton fetus at term. Parturient scheduled for elective lower segment cesarian section under spinal anethesia Exclusion Criteria: Patient refusal. Contraindications to spinal blockade, such cardiorespiratory problems, coagulopathy, neurological disease, psychological troubles, and allergy to the used drugs. Morbid obesity. Failure of spinal blockade. Emergency CS. Complicated pregnancy. Intrauterine fetal compromise.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yasser mamdouh hassan, assistant lecturer
    Phone
    01090433083
    Email
    yassermamdouh486@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed mohamed abbas, assistant professor
    Phone
    01003385183
    Email
    ahmedabbas@aun.edu.eg

    12. IPD Sharing Statement

    Links:
    URL
    https://www.semanticscholar.org/paper/Current-concepts-in-neuraxial-administration-of-and-Saxena-Arava/f8feed1a9cb941062de1ba8275d4928fc7c3680b
    Description
    Related Info
    URL
    https://link.springer.com/article/10.1007/s12630-017-0894-0
    Description
    Related Info
    URL
    https://pubmed.ncbi.nlm.nih.gov/11374604/
    Description
    Related Info
    URL
    https://pubmed.ncbi.nlm.nih.gov/25024471/
    Description
    Related Info
    URL
    https://jcdr.net/article_fulltext.asp?issn=0973-709x&year=2022&month=October&volume=16&issue=10&page=UC35-UC39&id=17078
    Description
    Related Info

    Learn more about this trial

    Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section

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