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Clinical Trials/NCT02878512
NCT02878512
Completed
Phase 4

Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis

Maharashtra University of Health Sciences0 sites60 target enrollmentJune 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Success Rate Under Segmental Epidural
Sponsor
Maharashtra University of Health Sciences
Enrollment
60
Primary Endpoint
Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shakuntala Basantwani

Associate Professor

Maharashtra University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Age - 18 years to 60 years
  • Either sex
  • BMI \< 30

Exclusion Criteria

  • Unwilling for consent
  • Obesity with BMI \>
  • Contraindications for Epidural Anaesthesia
  • Undilated pelvicalyceal system

Outcomes

Primary Outcomes

Hemodynamic parameters; change in Mean arterial pressures in mm Hg 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

change in mean arterial pressure from baseline

Hemodynamic parameters: Change in heart rate per minute from baseline

Time Frame: Every 15 minutes for 2 hours and then every hourly till 24 hours

Change in heart rate per minute from baseline

Postoperative Pain using VAS

Time Frame: Postoperatively every hourly for 24 hours

Post operative pain was studied using VAS

Secondary Outcomes

  • Surgeon satisfaction score(10 minutes Postoperative)

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