To study the postoperative pain in patients of lower limb surgeries

Phase 3

Not yet recruiting

• Conditions: Disorder of continuity of bone, unspecified,

• Registration Number: CTRI/2020/08/027214
• Lead Sponsor: NA

Brief Summary

Hyperbaric bupivacaine 0.5% iscommonlyused in spinal anesthesia. Hyperbaric solutions may cause sudden cardiac arrestdue to hypotension, bradycardia because of higher extend of sympatheticblockade. The use of isobaric solutions may decrease these risks. Levobupivacaineis preferred during spinal anesthesia due to its lower cardiovascularside-effects and central nervous system toxicity. Intrathecal adjuvants arecommonly used to improve the quality of intraoperative analgesia and extend itin the postoperative period without significant motor or autonomic blockade.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-14
• Study Start: 2020-08-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1.Patients undergoing lower limb surgeries 2.
• American Society of Anesthesiology (ASA) Grade I and II.

Exclusion Criteria

• 1.Neurological and musculoskeletal disease.
• 2.Patients with cardiovascular diseases.
• 3.Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
• 4.Hypersensitivity to study drugs 5.Pregnant women 6.History of opioid dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the duration of postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries.	pain will be assessed from 0 min till the 24 hours of the surgery

Secondary Outcome Measures

Name	Time	Method
to evaluate the sedative and adverse effects of all the three drugs in the lower limb surgeries	effects will be assessed from 0 min till the 24 hours of the surgery

Trial Locations

Locations (1)

Sri Guru Ram Das Institute of Medical Sciences & Research; 🇮🇳 Amritsar, PUNJAB, India

Sri Guru Ram Das Institute of Medical Sciences & Research

🇮🇳Amritsar, PUNJAB, India

Dr Ruchi Gupta

Principal investigator

9814320805

drruchisgrd@gmail.com