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Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Bupivacain
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult patients aged 18-60 years. Gender: Both males and females. Scheduled patients for High tibial osteotomy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II Exclusion Criteria: Patient refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Group M (midazolam group)

    Group D(dexmedetomidine group)

    Group C(control group)

    Arm Description

    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 1 mg midazolam (8 units of 5 mg/mL preservative-free midazolam loaded in a 40 unit insulin syringe).

    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 5 mcg dexmedetomidine (2 units of 100 mcg/mL preservative-free dexmedetomidine loaded in a 40 unit insulin syringe).

    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 0.5 mL of 0.9% saline .

    Outcomes

    Primary Outcome Measures

    Time to first analgesic request
    Time to first analgesic request calculated from the administration of local anesthetic

    Secondary Outcome Measures

    analgesic consumption
    Total analgesic consumption in the first 24 hour .
    Incidence of complications
    Incidence of complications (bradycardia , hypotension ,nausea and vomiting).

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082232
    Brief Title
    Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia
    Official Title
    Intrathecal Dexmedetomidine Versus Midazolam as Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia in High Tibial Osteotomy. A Randomized, Prospective, Double- Blinded, Comparative Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (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 the postoperative analgesic effect of intrathecal dexmedetomidine combined with bupivacaine and midazolam combined with bupivacaine in high tibial osteotomy.
    Detailed Description
    With more than 80% of patients experiencing acute pain following surgical procedures, and half of them reporting inadequate pain therapy, the control and management of post-surgical pain remains one of the most challenging aims of modern anesthesia. Adequate postoperative pain control is an important part of postoperative care treatment. World Health Organization, as well as International Association for the Study of Pain, have emphasized its significance for patients well-being, and determined pain relief to be a human right and the occurrence of pain as fifth vital sign. Local anesthetic, bupivacaine, is the most common agent used for spinal anesthesia but has relatively short duration of action. Many adjuvants to local anesthetics have been used intrathecally to improve the quality of intraoperative analgesia and prolong it in the postoperative period. Diverse classes of drugs such as opioids , epinephrine , neostigmine , magnesium , midazolam , ketamine , and clonidine have been added to intrathecal local anaesthetics in an attempt to prolong analgesia and reduce the incidence of adverse events. Opioids are commonly added to local anaesthetics to produce spinal and epidural anesthesia. However, significant adverse effects such as, urinary retention, respiratory depression, hemodynamic instability, pruritus and occasionally severe nausea and vomiting, may limit their use . α2-adrenergic agonists are new neuraxial adjuvants being studied to improve the quality of subarachnoid blockade regarding both sensory and motor blockades. There are many studies supporting their efficacy as adjuvants individually. Dexmedetomidine, a highly specific, potent, and selective α2-adrenergic agonist, provides stable hemodynamic conditions and good quality of intraoperative and prolonged postoperative analgesia with minimal side effects. Discovery of benzodiazepine receptors in spinal cord in 1977 triggered the use of intrathecal midazolam for prolongation of spinal anesthesia.

    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
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group M (midazolam group)
    Arm Type
    Active Comparator
    Arm Description
    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 1 mg midazolam (8 units of 5 mg/mL preservative-free midazolam loaded in a 40 unit insulin syringe).
    Arm Title
    Group D(dexmedetomidine group)
    Arm Type
    Active Comparator
    Arm Description
    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 5 mcg dexmedetomidine (2 units of 100 mcg/mL preservative-free dexmedetomidine loaded in a 40 unit insulin syringe).
    Arm Title
    Group C(control group)
    Arm Type
    Placebo Comparator
    Arm Description
    includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 0.5 mL of 0.9% saline .
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Under strict aseptic conditions, a lumbar puncture will be performed with selective technique in sitting position at L2-3 or L3-4 interspaces with midline approach using a 25-G Quincke's needle. After achieving the free flow of cerebrospinal fluid, the study drug will be injected into the subarachnoid space, immediately after injection the patient will be asked for supine position.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    1 mg midazolam intrathecal administration
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacain
    Intervention Description
    20 mg bupivacaine intrathecal administration
    Primary Outcome Measure Information:
    Title
    Time to first analgesic request
    Description
    Time to first analgesic request calculated from the administration of local anesthetic
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    analgesic consumption
    Description
    Total analgesic consumption in the first 24 hour .
    Time Frame
    24 hours
    Title
    Incidence of complications
    Description
    Incidence of complications (bradycardia , hypotension ,nausea and vomiting).
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients aged 18-60 years. Gender: Both males and females. Scheduled patients for High tibial osteotomy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II Exclusion Criteria: Patient refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Farghali
    Phone
    +201068914686
    Email
    ahmedsayedali2016@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Youssef
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mahmoud Kamel
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17578977
    Citation
    Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
    Results Reference
    background
    PubMed Identifier
    8706199
    Citation
    Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
    Results Reference
    background
    PubMed Identifier
    16430546
    Citation
    Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.
    Results Reference
    background
    PubMed Identifier
    918669
    Citation
    Mohler H, Okada T. Benzodiazepine receptor: demonstration in the central nervous system. Science. 1977 Nov 25;198(4319):849-51. doi: 10.1126/science.918669.
    Results Reference
    background

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    Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia

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