Post surgery pain relief following lumbar spine surgeries
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/06/054101
- Lead Sponsor
- SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL, TUMKUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Patients belonging to ASA class I, II
2) Patients undergoing lumbar spine (L1-L5) surgeries under General Anaesthesia.
3)BMI < 29.9 kg/m2
4) Patient who has given valid informed consent
Exclusion Criteria
1)Patient’s refusal.
2) Bleeding disorders (platelets count <1,50,000; international normalized ratio >1.5;PC <60%) and coagulopathies.
3) Skin lesions, wounds or infection at the injections site.
4) Known allergy to local anesthetic drugs.
5) Chronic opioid or NSAIDS users.
6) Patients with pre-operative opioid consumption.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first analgesia requestTimepoint: immediately, 30 mins, 1 hour, 2, 6 and 12 hour after injection.
- Secondary Outcome Measures
Name Time Method - Presence of any complications immediately <br/ ><br>- Presence of any complications such as urine retention, vomiting , <br/ ><br>respiratory depression. <br/ ><br>- Mean arterial blood pressure [ Time Frame: every 5 minutes intraoperative till end of surgery (up to 2 hours) ]intraoperative mean arterial blood pressure. <br/ ><br>- Heart rate [ Time Frame: every 5 minutes intraoperative till end of surgery(up to 2 hours) ] intraoperative heart rate. <br/ ><br>- VAS score [ Time Frame: at 30 mins, then at 1, 2, 6, 12, 24 hours post-operatively ]The visual analog score(VAS) is a validated, subjective measure for acute and chronic pain. scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between no pain and worst pain. <br/ ><br>Timepoint: 1,2,6,12,24 hrs after injection