compare the after surgery pain prevention effect of two different doses of drug

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/07/043635
• Lead Sponsor: SGRDIMSAR

Brief Summary

Hyperbaric bupivacaine 0.5% iscommonly used in spinalanesthesia. Hyperbaric solutions may cause sudden cardiac arrest due tohypotension, bradycardia because of higher extend of sympathetic blockade. Theuse of isobaric solutions may decrease these risks. LEVOBUPIVACAINE is newerdrug and should be  preferred duringspinal anesthesia due to its lower cardiovascular side-effects and centralnervous system toxicity. Intrathecal adjuvants are commonly used to improve thequality of intraoperative analgesia and extend it in the postoperative periodwithout significant motor or autonomic blockade.

Thestudy will consist of 90 patients randomly divided into three groups of 30each- group A:0.5% Isobaric LEVOBUPIVACAINE15mg + 100mg magnesium sulphate diluted in N.S(0.2ml),group B: 0.5% isobaric LEVOBUPIVACAINE 15mg +75mgmagnesium sulphate diluted inN.S. (0.2 ml)and group C: only isobaric LEVOBUPIVACAINE 0.5%+0.2ML(NS)intrathecally. These groups will be compared with respect to onset and durationof sensory and motor blockade, duration of postoperative analgesia, sedationscore, side effects and complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Last Update Posted: 2022-08-07

Recruitment & Eligibility

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

Inclusion Criteria

Patients undergoing infra-umbilical surgeries American Society of Anesthesiology (ASA) Grade I and II Hemodyanamically stable.

Exclusion Criteria

• 1.Neurological and musculoskeletal disease.
• 2.Patients with cardiovascular diseases.
• 3.Contraindications to regional anesthesia such as patient refusal, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Compare Post Operative Analgesic effect of Two Different Doses of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Sub-Arachnoid Block for Infra-Umbilical Surgeries	from the time of giving spinal anaesthesia till 24 hours postopertively

Secondary Outcome Measures

Name	Time	Method
Complications	from the time of giving spinal anaesthesia till 24 hours postopertively

Trial Locations

Locations (1)

SGRD Hospital; 🇮🇳 Amritsar, PUNJAB, India

SGRD Hospital

🇮🇳Amritsar, PUNJAB, India

Dr Ruchi Gupta

Principal investigator

9814320805

drruchisgrd@gmail.com