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

Phase 4

Completed

• Conditions: Post Operative Pain; Success Rate Under Segmental Epidural
• Interventions: Procedure: Segmental Epidural Anesthesia; Procedure: PCNL under General Anesthesia

• Registration Number: NCT02878512
• Lead Sponsor: Maharashtra University of Health Sciences

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2016-06-23
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-21
• Last Update Submitted: 2016-08-21
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCNL under Segmental epidural Anesthesia	Segmental Epidural Anesthesia	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.
PCNL under General Anesthesia	PCNL under General Anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameters; change in Mean arterial pressures in mm Hg 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	change in mean arterial pressure from baseline
Hemodynamic parameters: Change in heart rate per minute from baseline	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	Postoperatively every hourly for 24 hours	Post operative pain was studied using VAS

Secondary Outcome Measures

Name	Time	Method
Surgeon satisfaction score	10 minutes Postoperative	(0-extremely poor, 1-poor, 2-fair, 3-good, 4-excellent).