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

NCT02878512 | Completed Phase 4 DMC

• 1 other identifier: IEC/69/16
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Success Rate Under Segmental Epidural; Post Operative Pain

Keywords

Segmental Epidural; Regional Anesthesia for PCNL

Outcome Measures

Primary Outcomes (3)

• 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

• Postoperative Pain using VAS

  Post operative pain was studied using VAS

  Postoperatively every hourly for 24 hours

• 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

Secondary Outcomes (1)

• Surgeon satisfaction score

  10 minutes Postoperative

Study Arms (2)

PCNL under General Anesthesia

ACTIVE COMPARATOR

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.

Procedure: PCNL under General Anesthesia

PCNL under Segmental epidural Anesthesia

EXPERIMENTAL

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.

Procedure: Segmental Epidural Anesthesia

Interventions

PCNL under General Anesthesia PROCEDURE

Patients undergoing percutaneous Nephrolithotomy received General anesthesia.

PCNL under General Anesthesia

Segmental Epidural Anesthesia PROCEDURE

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

Also known as: Regional Anesthesia

PCNL under Segmental epidural Anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I/II
• Age - 18 years to 60 years
• Either sex
• BMI \< 30

You may not qualify if:

• Unwilling for consent
• ASA 3
• Obesity with BMI \> 30.
• Contraindications for Epidural Anaesthesia
• Undilated pelvicalyceal system

Sponsors & Collaborators

• Maharashtra University of Health Sciences: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: August 25, 2016
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share