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Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy

Primary Purpose

Analgesia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine Injection [Precedex]
Lidocaine IV
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient's status ASA status-I and II. Patients age above 18 years old. Patients scheduled for laparoscopic cholecystectomy. Exclusion Criteria: Patient refusal. Patients with known allergy to dexmedetomidine or lidocaine. Patients with significant hepatic dysfunction. Patients with severe renal disease. Patients with chronic pain. Regular use analgesics, antidepressants or opioids in last month. Any known convulsive disorder. Significant heart disease. Morbid obesity (BMI>35). Patients with autoimmune disease Patients on corticosteroid therapy Pregnancy Breast feeding Woman under hormonal treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dexmedetomidine group

    Lidocaine group

    Arm Description

    This group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].

    This group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance].

    Outcomes

    Primary Outcome Measures

    Numeric Pain Rating Scale
    Numeric Pain Rating Scale (NPRS) will be explained to the patient to be able to choose the score that best expressed the intensity of pain postoperatively ranging from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".

    Secondary Outcome Measures

    Richmond Agitation-Sedation Scale
    Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the level of sedation in post-anesthesia care unit (PACU), It is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation, ranging from +4 to -5, desirable score is 0 to -2.
    First call for rescue analgesic (Nalbuphine)
    The total postoperative Nalbuphine consumption
    Intraoperative automated non-invasive blood pressure monitoring.
    Intraoperative electrocardiogram (ECG) heart rate monitoring.
    The mean duration of PACU stay.

    Full Information

    First Posted
    January 17, 2023
    Last Updated
    March 26, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05788393
    Brief Title
    Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy
    Official Title
    Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy a Randomized Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    February 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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Opioid sparing analgesia: Continuous intraoperative infusion of dexmedetomidine versus lidocaine for laparoscopic cholecystectomy, a randomized double-blind clinical trial.
    Detailed Description
    Postoperative pain represents one of the most common complaints following surgeries. Despite advances in modern medicine, pain following surgical procedures is still a challenge for anesthetists, though significant progress made over the past decades. The mechanism of pain following laparoscopic procedures is thought to be multifactorial. The main causes of pain after laparoscopic cholecystectomy (LC) are pain from the incision site, pneumoperitoneum and cholecystectomy. Clinicians using different methods for analgesia after LC. like non-steroidal anti-inflammatory drugs, intraperitoneal local anesthetics, local anesthetics applied to the wound site, removal of the insufflation gas, paravertebral block (PVB), and epidural block. To date, the mainstay of management has been the administration of exogenous opioids such as morphine or fentanyl. However, pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. In addition to that, many patients and even some clinicians wrongly believe that addiction can be inevitable after administration of opioids. Dexmedetomidine is an alpha 2-adrenergic agonist which is a relatively new drug used for procedural sedation. It has sedative and anxiolytic effects and is known for its analgesic potential owing to a reduction of sympathetic tone. Dexmedetomidine has dose-dependent effects, ranging from minimal to deep sedation. Moreover, except at doses that cause very deep sedation or general anesthesia, the sedation is reversible. These are unique properties among the sedative medications in common use. Dexmedetomidine does not impair the respiratory drive per se and seldom causes apnea. However, it has been shown to impair the respiratory responses to hypoxia and hypercapnia and can cause hemodynamic effects such as hypertension, hypotension and bradycardia. Systemic lidocaine has centrally and peripherally analgesic, anti-hyperalgesic and anti-inflammatory effects with reduced side-effects especially if used with appropriate dose. Recently, intravenous lidocaine infusion is considered a part of analgesic therapy regimen that decreases postoperative opioid requirements and enhances convalescence after major surgeries. Dexmedetomidine and lidocaine are common adjuvant medicine anesthetics during operation for the sedative and analgesic properties. Besides, some studies have proved that both are effective in relieving postoperative pain in adults. However, there are very limited studies comparing the effects of the two adjuvant analgesics on postoperative pain in patients undergoing laparoscopic cholecystectomy (LC).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    this study is to compare the effects of continuous intraoperative infusion of dexmedetomidine versus lidocaine as opioid sparing analgesia on patients undergoing laparoscopic cholecystectomy.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine group
    Arm Type
    Experimental
    Arm Description
    This group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].
    Arm Title
    Lidocaine group
    Arm Type
    Experimental
    Arm Description
    This group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance].
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine Injection [Precedex]
    Intervention Description
    dexmedetomidine group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine IV
    Intervention Description
    lidocaine group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance]. The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.
    Primary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale
    Description
    Numeric Pain Rating Scale (NPRS) will be explained to the patient to be able to choose the score that best expressed the intensity of pain postoperatively ranging from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    Richmond Agitation-Sedation Scale
    Description
    Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the level of sedation in post-anesthesia care unit (PACU), It is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation, ranging from +4 to -5, desirable score is 0 to -2.
    Time Frame
    15 minutes
    Title
    First call for rescue analgesic (Nalbuphine)
    Time Frame
    1 day
    Title
    The total postoperative Nalbuphine consumption
    Time Frame
    1 day
    Title
    Intraoperative automated non-invasive blood pressure monitoring.
    Time Frame
    1 hour
    Title
    Intraoperative electrocardiogram (ECG) heart rate monitoring.
    Time Frame
    1 hour
    Title
    The mean duration of PACU stay.
    Time Frame
    3 hours
    Other Pre-specified Outcome Measures:
    Title
    Side effects of study drugs.
    Time Frame
    1 hour
    Title
    Satisfaction of the patients questionnaire
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient's status ASA status-I and II. Patients age above 18 years old. Patients scheduled for laparoscopic cholecystectomy. Exclusion Criteria: Patient refusal. Patients with known allergy to dexmedetomidine or lidocaine. Patients with significant hepatic dysfunction. Patients with severe renal disease. Patients with chronic pain. Regular use analgesics, antidepressants or opioids in last month. Any known convulsive disorder. Significant heart disease. Morbid obesity (BMI>35). Patients with autoimmune disease Patients on corticosteroid therapy Pregnancy Breast feeding Woman under hormonal treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina D. Hanna, Dr
    Phone
    +201211589667
    Email
    mina.daniel12@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed S. Saad, Dr
    Organizational Affiliation
    Assiut university hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29619627
    Citation
    Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018 Apr 4;22(5):35. doi: 10.1007/s11916-018-0690-8.
    Results Reference
    background
    PubMed Identifier
    21811368
    Citation
    Meera A. Pain and Opioid Dependence: Is it a Matter of Concern. Indian J Palliat Care. 2011 Jan;17(Suppl):S36-8. doi: 10.4103/0973-1075.76240.
    Results Reference
    background
    PubMed Identifier
    28107373
    Citation
    Barends CR, Absalom A, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety. PLoS One. 2017 Jan 20;12(1):e0169525. doi: 10.1371/journal.pone.0169525. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    32297162
    Citation
    Batko I, Koscielniak-Merak B, Tomasik PJ, Kobylarz K, Wordliczek J. Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study. Pharmacol Rep. 2020 Jun;72(3):744-755. doi: 10.1007/s43440-020-00100-7. Epub 2020 Apr 15.
    Results Reference
    background
    PubMed Identifier
    26861737
    Citation
    Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
    Results Reference
    background
    PubMed Identifier
    27199310
    Citation
    Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
    Results Reference
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    PubMed Identifier
    3785962
    Citation
    Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
    Results Reference
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    PubMed Identifier
    12421743
    Citation
    Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
    Results Reference
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    Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy

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