Clinical trial NCT02878512: Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Success Rate Under Segmental Epidural
Post Operative Pain
Keywords: Segmental Epidural
Regional Anesthesia for PCNL
Lead sponsor: Maharashtra University of Health Sciences
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Hemodynamic parameters: Change in heart rate per minute from baseline
timeFrame: Every 15 minutes for 2 hours and then every hourly till 24 hours
measure: Postoperative Pain using VAS
timeFrame: Postoperatively every hourly for 24 hours
measure: Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
timeFrame: Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours
Secondary outcomes:
measure: Surgeon satisfaction score
timeFrame: 10 minutes Postoperative
Other outcomes:
Locations:
Study officials:
References: