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Clinical Trials/CTRI/2024/07/070390
CTRI/2024/07/070390Not yet recruitingPhase 4

Comparative study of 0.5% Levo-bupivacaine versus 0.5% Ropivacaine in combined sciatic and femoral nerve block in below knee orthopedic surgery under ultrasound guidance.

Rajendra institute of medical science1 site in 1 country46 target enrollmentStarted: July 20, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
46
Locations
1
Primary Endpoint
To evaluate the efficacy of 0.5% Levo-bupivacaine versus 0.5% Ropivacaine in combined sciatic and femoral nerve block under ultrasound guidance in patients undergoing below knee orthopaedic surgery

Study Overview

Brief Summary

Regional anaesthesia are increasingly the preferred and best option for wide range of lower limb surgeries.It is said to provide surgical anaesthesia with better cardio- respiratory stability and to cause least interferance with the vital physiological function of the body.

Levo-bupivacaine has strongly emerged as a safer alternative for regional anaesthesia and is less cardiotoxic. Ropivacaine is documented to have comparable levels and duration of analgesia, lesser cardiotoxicity for the same duration of analgesia in comparison to Bupivacaine.

The purpose of the present study is to evaluate the efficacy of 0.5% Levo-bupivacaine and 0.5% Ropivacaine in combined sciatic and femoral nerve block for below knee orthopaedic surgery, by studying the onset and duration of sensory and motor blockade and the hemodynamic changes.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA grade 1 and 2, no known neurological deficit, surgery.
  • orthopaedic surgery below knee.

Exclusion Criteria

  • ASA grade 3 and 4, patient with neurological disorders, history of allergy to study drug.

Outcomes

Primary Outcomes

To evaluate the efficacy of 0.5% Levo-bupivacaine versus 0.5% Ropivacaine in combined sciatic and femoral nerve block under ultrasound guidance in patients undergoing below knee orthopaedic surgery

Time Frame: After induction | End of surgery | 12 hour postoperative

Secondary Outcomes

  • To study hemodynamic changes of 0.5% Levo-bupivacaine and 0.5% Ropivacaine(After induction)

Investigators

Sponsor
Rajendra institute of medical science
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Prity Rani Tirkey

Rajendra institute of medical science, Ranchi

Study Sites (1)

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