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Clinical Trials/CTRI/2023/06/054101
CTRI/2023/06/054101Not yet recruitingUnknown

Comparative evaluation of ultrasound guided bilateral erector spinae block and ultrasound guided caudal block in lumbar spine surgeries for postoperative analgesia

SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL, TUMKUR1 site in 1 country40 target enrollmentStarted: June 27, 2023Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Time to first analgesia request

Study Overview

Brief Summary

A hospital based  comparative evaluaton of ultrasound guided bilateral erector spinae block and ultrasound guided caudal block in lumbar spinae surgeries for post operative analgesia .

INTRODUCTION:

pain : it is unpleasant sensation that can be very severe requiring large doses of opiods resulting in respiratory depression ,vomiting and pruritis .

so,regional anaesthesia techniques for postoperative analgesia overcomes these complication of opiods. Erector spinae block and caudal block will be evaluated in study for post operative analgesia.

ASA1&2 patients aged 18to 65 years posted for lumbar spine surgeries (L1-L5) at sri siddartha medical college and research centre ,tumkur will be selected for the study period of 24 months with sample size 40 patients .

All patients as per inclusion and exclusion criteria posted for elective orthopaedic surgical procedures will be taken in the study .

Methodology : the data is collected by convenient sampling .the data will be entered in excel spread sheet .Descriptive

statistical analysis will be carried out .Quantitive variables will be  presented as frequency and percentages .The associaton between categorical variables will be analysed by applying chi square test .The data will be analysed by using SPSS software (version 20)

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients belonging to ASA class I, II 2) Patients undergoing lumbar spine (L1-L5) surgeries under General Anaesthesia.
  • •BMI < 29.9 kg/m2 4) Patient who has given valid informed consent.

Exclusion Criteria

  • •Patient’s refusal.
  • •Bleeding disorders (platelets count <1,50,000; international normalized ratio >1.5;PC<60%) and coagulopathies.
  • •Skin lesions, wounds or infection at the injections site.
  • •Known allergy to local anesthetic drugs.
  • •Chronic opioid or NSAIDS users.
  • •Patients with pre-operative opioid consumption.

Outcomes

Primary Outcomes

Time to first analgesia request

Time Frame: immediately, 30 mins, 1 hour, 2, 6 and 12 hour after injection.

Secondary Outcomes

  • - Presence of any complications immediately(- Presence of any complications such as urine retention, vomiting ,)

Investigators

Sponsor
SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL, TUMKUR
Sponsor Class
Private medical college

Study Sites (1)

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