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NCT Number: NCT02878512

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCNL under General Anesthesia

Procedure

Patients undergoing percutaneous Nephrolithotomy received General anesthesia.

Segmental Epidural Anesthesia

Procedure

Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.

Other names: Regional Anesthesia

Primary outcomes

  1. 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

  2. Postoperative Pain using VAS

    Time frame: Postoperatively every hourly for 24 hours

    Post operative pain was studied using VAS

  3. 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

Secondary outcomes

  1. Surgeon satisfaction score

    Time frame: 10 minutes Postoperative

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

Sponsors and collaborators

Lead sponsor

Maharashtra University of Health Sciences

Other

Registry information

Official study title

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

Acronym: AnesthesiaPCNL

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2016
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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