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Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy

Primary Purpose

Stone, Kidney

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single shot ESBP with dexmedtomidine
continous ESPB
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stone, Kidney

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy

Exclusion Criteria:

  • - Body mass index greater than 35 kg/m2.
  • Pregnancy.
  • Unstable coronary artery disease, congestive heart failure, or arrhythmias.
  • Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
  • Pre-existing neurological deficits or neuropathy.
  • Significant psychiatric or cognitive conditions interfering with consent or assessment.
  • Significant renal impairment (creatinine above 2 mg/dl)
  • Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
  • Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
  • Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A (single shot,n=20)

    Group B (continous infusion,n=20)

    Arm Description

    Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB

    Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs;ESPB

    Outcomes

    Primary Outcome Measures

    Duration of postoperative Analgesia:
    "the time interval between extubation and the first request to postoperative analgesia

    Secondary Outcome Measures

    Duration of sensory block
    the time interval between the onset of successful sensory block and the first request to postoperative analgesia
    Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
    visual analogue scale during rest and movement

    Full Information

    First Posted
    November 13, 2020
    Last Updated
    December 2, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04650737
    Brief Title
    Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
    Official Title
    Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    December 29, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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 current study is designed to assess the efficacy of a single shot ESPB with Dexmedetomidineversus continuous ESPB in perioperative analgesia for PCNL. Both techniques are conducted for patients undergoing PCNL under GA.
    Detailed Description
    Successful perioperative pain management is one of the main goals of the whole anesthetic practice. Kidney Surgeries, especially those involving the renal pelvis warrant special analgesic considerations. This is due to the sensitivity of the renal pelvis to pain. Its sub-diaphragmatic position affects deep breathing and coughing. Which renders adequate analgesia an important factor for maintaining good respiratory force and depth postoperative and reduces respiratory complications like atelectasis. The Use of a single mode of analgesia in these settings , like the use of parenteral opioids for example, provides significantly less analgesic effect and more complications including respiratory depression , PONV (postoperative nausea and vomiting ) , constipation , urine retention …etc. The use of regional techniques as a part of multimodal pain management in these procedures provides superior analgesia and less complication rates. This is added to high expectations of an easier perioperative course of PCNL (percutaneous nephrolithotomy) being and endoscopic procedure that does not involve a big skin incision. These expectations also include a short hospital stay. However PCNL is usually associated with significant pain and discomfort postoperatively. Various studies have been studying effects of integrating local and regional techniques in the perioperative pain management. For Regional and local procedures of analgesia; Studies of Single Shot technique and catheter techniques has long been ongoing for many regional techniques for example like Pravertebral block and adductor canal block . These studies are conducted to determine the efficacy and adversities each technique. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block . Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine . Peri-neural dexmedetomidine was evaluated in animal studies where it prolonged the duration of sensory and motor blocks of local anesthetics without any evidence of neurotoxicity for up to 14 days after initial administration . The use of perineuraldexmedetomidine prolong the duration of of sensory block, provide effective acute pain control after surgery and reduce the need for rescue analgesia in several nerve blocks like upper limb extremity blocks,Paravertebral block), tranversus abdominis plane (TAP) block and Erector spinae plane block. Erector spinae plane block (ESPB) is a relatively novel procedure. The limited number of studies available show promising results as regards the efficacy of pain management in trunk surgeries and renal interventions. However the studies that clarify the different applications of ESPB, including the efficacy of a single shot versus a continuous block with an indwelling catheter, are lacking.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Both groups will receive Ultrasound guided ESPB before induction of general anesthesia Single shot group (A):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine. Continous infusion group (B):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (single shot,n=20)
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB
    Arm Title
    Group B (continous infusion,n=20)
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs;ESPB
    Intervention Type
    Drug
    Intervention Name(s)
    single shot ESBP with dexmedtomidine
    Intervention Description
    Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
    Intervention Type
    Drug
    Intervention Name(s)
    continous ESPB
    Intervention Description
    Patients in this group will receive erector spine plane block with 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs.
    Primary Outcome Measure Information:
    Title
    Duration of postoperative Analgesia:
    Description
    "the time interval between extubation and the first request to postoperative analgesia
    Time Frame
    post-operative period(24 hours)
    Secondary Outcome Measure Information:
    Title
    Duration of sensory block
    Description
    the time interval between the onset of successful sensory block and the first request to postoperative analgesia
    Time Frame
    24 hours
    Title
    Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
    Description
    visual analogue scale during rest and movement
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy Exclusion Criteria: - Body mass index greater than 35 kg/m2. Pregnancy. Unstable coronary artery disease, congestive heart failure, or arrhythmias. Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg. Pre-existing neurological deficits or neuropathy. Significant psychiatric or cognitive conditions interfering with consent or assessment. Significant renal impairment (creatinine above 2 mg/dl) Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea. Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy. Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    29885165
    Citation
    Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
    Results Reference
    background
    PubMed Identifier
    8017600
    Citation
    Schug SA, Fry RA. Continuous regional analgesia in comparison with intravenous opioid administration for routine postoperative pain control. Anaesthesia. 1994 Jun;49(6):528-32. doi: 10.1111/j.1365-2044.1994.tb03528.x.
    Results Reference
    background
    PubMed Identifier
    29288788
    Citation
    Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.
    Results Reference
    background
    PubMed Identifier
    19602964
    Citation
    Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.
    Results Reference
    background
    PubMed Identifier
    22762468
    Citation
    Farag E, Argalious M, Abd-Elsayed A, Ebrahim Z, Doyle DJ. The use of dexmedetomidine in anesthesia and intensive care: a review. Curr Pharm Des. 2012;18(38):6257-65. doi: 10.2174/138161212803832272.
    Results Reference
    background

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    Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy

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