Post Operative Pain Clinical Trial
— AnesthesiaPCNLOfficial title:
Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maharashtra University of Health Sciences |
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 |
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