A study to compare the clinical efficacy & safety of equal doses of Hyperbaric ropivacaine vs Hyperbaric bupivacaine for sub arachnoid block in knee arthroscopic surgery.

Not yet recruiting

• Conditions: Tear of meniscus, current injury, (2) ICD-10 Condition: S832||Tear of meniscus, current injury,

• Registration Number: CTRI/2023/09/057327
• Lead Sponsor: FORTIS HOSPITAL

Brief Summary

Our study is a randomised prospective double blind study that will be done to compare the efficacy and safety of the two study drugs namely hyperbaric 0.75% ropivacaine and  hyperbaric 0.5% bupivacaine. The study will be done in patients undergoing elective knee arthroscopic surgery being conducted at Fortis Hospital Mohali in the department of anaesthesia and critical care.

Sample size of eighty will be taken and block randomisation done with Computerized Randomization Technique. Both the drugs would be distributed among the participants. The effect of the study drugs will be assessed using parameters like the onset of sensory and motor blocks ,time for regression from T10 level, complete duration of block and side-effect profiles etc. At the end, result of both the drugs will be compared and statistically analysed .Any complications will also be recorded.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-09
• Study Start: 2023-09-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Willing to participate, ASA grade 1 and 2, Age- 16-65 years, Either gender scheduled for elective knee arthroscopic surgery under spinal anaesthesia, Pt with BMI less then 35, Patients who have given valid informed written consent.

Exclusion Criteria

• Patients of American society of Anaesthesiologists 3 and 4, Patient refusal , Infection at the site of administration, Coagulopathy , Spinal deformity, Allergic to local anesthetic drugs , Lack of informed written consent , Duration of surgery greater than 120 mins, Patients having allergy to study drug, Patients with psychiatric disorder or history of drug abuse.
• Patient unable to comprehend, Morbidly obese patients (BMI greater than 35kg per m2), Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the clinical efficacy & safety of equal doses 3ml of 0.75 % Hyperbaric ropivacaine with 3ml of 0.5% Hyperbaric bupivacaine for sub arachnoid block in knee arthroscopic surgery for a duration of 16 to 18 months	1.The onset of Sensory block till T 10 | 2.The onset of Motor block. | 3.Time for two segment regression of sensory block | 4.The complete duration of sensory & motor block | 5.Intraoperative Haemodynamics. | 6.Intraoperative complications. | 7.Time to first rescue analgesic. | 8.Time to micturition. | for a duration of 16 to 18 months

Secondary Outcome Measures

Name	Time	Method
To study & compare the side effect profile of the two drugs,	To study the intraoperative and post operative complications.

Trial Locations

Locations (1)

Fortis hospital mohali; 🇮🇳 Chandigarh, CHANDIGARH, India

Fortis hospital mohali

🇮🇳Chandigarh, CHANDIGARH, India

Dr Dinesh Kataria

Principal investigator

9872217274

drkat22in@gmail.com