Comparison of effect of Isobaric levobupivacaine – fentanyl and Isobaric levobupivacaine – buprenorphine in lower limb surgeries when given intrathecally.

Phase 4

Not yet recruiting

• Conditions: Patients Undergoing Lower Limb Surgeries Like Fractures , Skin Grafting , Ammputation ETC

• Registration Number: CTRI/2019/01/017093
• Lead Sponsor: MGM INSTITUTE OF HEALTH SCIENCES

Brief Summary

To compare theeffects of intrathecal isobaric levobupivacaine – fentanyl and isobaric levobupivacaine– buprenorphine for spinal anaesthesia in lower limbsurgeries with regards to spinalblock characteristics, post operative analgesia and intraoperative haemodynamicstability.

The following parameters are to be studied in each group.

·        Timeof onset of sensory block.

·        Maximumheight of sensory block.

·        Durationof sensory block as regression to L1

·        Timeof onset of motor block.

·        Durationof motor block.

·        Durationof post operative analgesia

·        Intraoperative changes in heart rate and mean blood pressure.

·        Sideeffects such as nausea vomiting, pruritus and respiratory depression

To compareall the above parameter in both the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age group between 18 to 65 years Sex- Male/Female ASA Grade 1, 2, 3 Lower limb surgeries (both Orthopaedic and general surgery) Height between 140 cm to 180 cm.

Exclusion Criteria

• Contraindications of spinal anaesthesia such as: Local infection, Raised intra cranial tension, Coagulopathy, Valvular heart disease.
• Known allergies to the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of onset of sensory block.	6 Hours
Maximum height of sensory block.	6 Hours
Duration of sensory block as regression to L1	6 Hours
Time of onset of motor block.	6 Hours
Duration of motor block.	6 Hours
Duration of post operative analgesia	6 Hours

Secondary Outcome Measures

Name	Time	Method
Duration of post operative analgesia	Intra operative changes in heart rate and mean blood pressure.

Trial Locations

Locations (1)

MGM Medical College and Hospital , Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

MGM Medical College and Hospital , Aurangabad

🇮🇳Aurangabad, MAHARASHTRA, India

PREET FURIA

Principal investigator

9920837720

preet.tiger@gmail.com