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

Post Operative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878512
• Other study ID #: IEC/69/16
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2016
• Last updated: August 21, 2016
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2016
• Source: Maharashtra University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bahrain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Success Rate Under Segmental Epidural

Intervention

Procedure:
• PCNL under General Anesthesia
Patients undergoing percutaneous Nephrolithotomy received General anesthesia.
• Segmental Epidural Anesthesia
Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharashtra University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic parameters: Change in heart rate per minute from baseline	Change in heart rate per minute from baseline	Every 15 minutes for 2 hours and then every hourly till 24 hours	No
Primary	Postoperative Pain using VAS	Post operative pain was studied using VAS	Postoperatively every hourly for 24 hours	No
Primary	Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline	change in mean arterial pressure from baseline	Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours	No
Secondary	Surgeon satisfaction score	(0-extremely poor, 1-poor, 2-fair, 3-good, 4-excellent).	10 minutes Postoperative	No