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Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL (AnesthesiaPCNL)

Primary Purpose

Success Rate Under Segmental Epidural, Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PCNL under General Anesthesia
Segmental Epidural Anesthesia
Sponsored by
Maharashtra University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Success Rate Under Segmental Epidural focused on measuring Segmental Epidural, Regional Anesthesia for PCNL

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I/II
  • Age - 18 years to 60 years
  • Either sex
  • BMI < 30

Exclusion Criteria:

  • Unwilling for consent
  • ASA 3
  • Obesity with BMI > 30.
  • Contraindications for Epidural Anaesthesia
  • Undilated pelvicalyceal system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PCNL under General Anesthesia

    PCNL under Segmental epidural Anesthesia

    Arm Description

    Patients were premedicated with Inj. Atropine 0.06 mg intramuscularly half an hour prior to surgery, IV ranitidine 1mg kg-1, IV ondansetron 0.08mg kg-1 IV midazolam 0.02mg kg-1 and Pentazocine 0.3 mg/kg. Anaesthesia was induced with IV Thiopentone sodium 3-5 mg kg-1 and Vecuronium 0.1mg kg-1.and then intubated. Anaesthesia was maintained on 50 %:50% nitrous oxide and oxygen, vecuronium and propofol infusion . At the end of the surgery postoperative analgesia was given with IV tarmadol and local nfiltration with 0.25% bupivacaine at the surgical site. Patients were reversed with IV glycopyrrolate 0.008mg kg-1 and IV neostigmine 0.06mg kg-1 and extubated.

    epidural space was located at T12 -L1 or L1-L2 space .The epidural catheter was inserted cephalad 5 cm upwards in the epidural space (tip approximately at T8 to T9). and test dose of 3 ml of 2% Adrenalized Lignocaine was administered..loading dose of 0.5% Bupivacaine, approximately 8 to 10 ml was injected epidurally with regular negative aspiration to block T6- T12 segments, if desired level was not achieved then additional dose of 1 to 1.5 ml 0.5% bupivacaine per spared segment was given to achieve the desired level.Motor blockade of the lower limbs was checked and noted before lithotomy, before prone and at the end of the surgery using Bromage scale. After two segment regression of sensory level epidural top up with 1/4th of initial dose 2 to 3 ml of 0.5% Bupivacaine was given. At the end of the surgery 8ml of 0.125% Bupivacaine was administered for postoperative analgesia and the catheter was removed.

    Outcomes

    Primary Outcome Measures

    Hemodynamic parameters: Change in heart rate per minute from baseline
    Change in heart rate per minute from baseline
    Postoperative Pain using VAS
    Post operative pain was studied using VAS
    Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
    change in mean arterial pressure from baseline

    Secondary Outcome Measures

    Surgeon satisfaction score
    (0-extremely poor, 1-poor, 2-fair, 3-good, 4-excellent).

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    August 21, 2016
    Sponsor
    Maharashtra University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02878512
    Brief Title
    Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL
    Acronym
    AnesthesiaPCNL
    Official Title
    Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharashtra University of Health Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard for this surgery.The advent of new drugs has refined the technique of general anaesthesia. However there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications. Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the surgical site. This not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. Selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our current study. In the present study the investigators aimed to evaluate the efficacy of segmental epidural for PCNL and compared it with standard technique i.e. GA.
    Detailed Description
    To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL surgery who received either General anesthesia or Segmental epidural Anesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Success Rate Under Segmental Epidural, Post Operative Pain
    Keywords
    Segmental Epidural, Regional Anesthesia for PCNL

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCNL under General Anesthesia
    Arm Type
    Active Comparator
    Arm Description
    Patients were premedicated with Inj. Atropine 0.06 mg intramuscularly half an hour prior to surgery, IV ranitidine 1mg kg-1, IV ondansetron 0.08mg kg-1 IV midazolam 0.02mg kg-1 and Pentazocine 0.3 mg/kg. Anaesthesia was induced with IV Thiopentone sodium 3-5 mg kg-1 and Vecuronium 0.1mg kg-1.and then intubated. Anaesthesia was maintained on 50 %:50% nitrous oxide and oxygen, vecuronium and propofol infusion . At the end of the surgery postoperative analgesia was given with IV tarmadol and local nfiltration with 0.25% bupivacaine at the surgical site. Patients were reversed with IV glycopyrrolate 0.008mg kg-1 and IV neostigmine 0.06mg kg-1 and extubated.
    Arm Title
    PCNL under Segmental epidural Anesthesia
    Arm Type
    Experimental
    Arm Description
    epidural space was located at T12 -L1 or L1-L2 space .The epidural catheter was inserted cephalad 5 cm upwards in the epidural space (tip approximately at T8 to T9). and test dose of 3 ml of 2% Adrenalized Lignocaine was administered..loading dose of 0.5% Bupivacaine, approximately 8 to 10 ml was injected epidurally with regular negative aspiration to block T6- T12 segments, if desired level was not achieved then additional dose of 1 to 1.5 ml 0.5% bupivacaine per spared segment was given to achieve the desired level.Motor blockade of the lower limbs was checked and noted before lithotomy, before prone and at the end of the surgery using Bromage scale. After two segment regression of sensory level epidural top up with 1/4th of initial dose 2 to 3 ml of 0.5% Bupivacaine was given. At the end of the surgery 8ml of 0.125% Bupivacaine was administered for postoperative analgesia and the catheter was removed.
    Intervention Type
    Procedure
    Intervention Name(s)
    PCNL under General Anesthesia
    Intervention Description
    Patients undergoing percutaneous Nephrolithotomy received General anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Segmental Epidural Anesthesia
    Other Intervention Name(s)
    Regional Anesthesia
    Intervention Description
    Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.
    Primary Outcome Measure Information:
    Title
    Hemodynamic parameters: Change in heart rate per minute from baseline
    Description
    Change in heart rate per minute from baseline
    Time Frame
    Every 15 minutes for 2 hours and then every hourly till 24 hours
    Title
    Postoperative Pain using VAS
    Description
    Post operative pain was studied using VAS
    Time Frame
    Postoperatively every hourly for 24 hours
    Title
    Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
    Description
    change in mean arterial pressure from baseline
    Time Frame
    Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours
    Secondary Outcome Measure Information:
    Title
    Surgeon satisfaction score
    Description
    (0-extremely poor, 1-poor, 2-fair, 3-good, 4-excellent).
    Time Frame
    10 minutes Postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA I/II Age - 18 years to 60 years Either sex BMI < 30 Exclusion Criteria: Unwilling for consent ASA 3 Obesity with BMI > 30. Contraindications for Epidural Anaesthesia Undilated pelvicalyceal system

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL

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