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Clinical Trials/CTRI/2025/02/081088
CTRI/2025/02/081088Not yet recruitingNot Applicable

A comparative study of dexmedetomidine vs clonidine as an adjuvent to local anaesthetic drug in supraclavicular brachial plexus block.

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 site in 1 country60 target enrollmentStarted: March 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj Clonidine vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia

Study Overview

Brief Summary

A COMPARATIVE OF DEXMEDETOMIDINE VS CLONIDINE AS AN  ADJUVANT TO LOCAL ANAESTHETIC DRUG IN SUPRACLAVICULAR  BRACHIAL PLEXUS BLOCK

OBJECTIVE:To observe and compare Onset and duration of sensory and motor block, To observe and compare Duration of analgesia,To compare Perioperative hemodynamic changes & any adverse effects

INCLUSION CRITERIA:

Patient willing to sign inform consent.

ASA grade I and II patients posted for elective upper limb surgeries under

Supraclavicular Brachial Plexus Block

Age: 18-65 years

EXCLUSION CRITERIA:Patient refusal

Infection at local site

Hypersensitivity or Allergy to local anaesthetic agent

Coagulation disorders

Patient on Anticoagulants

Alcoholic or patient with drug abuse

Patients receiving any drug that interact with our study drug

Pre Existing Nerve injury

Inadequate effect of nerve block or supplemented with other type of

anaesthesia

SAMPLE SIZE AND GROUP

Group-1 :Patients who have received inj. Bupivacaine 0.5% 20 ml  with inj. Dexmedetomidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block.

Group-2: patients who have received inj. Bupivacaine 0.5% 20 ml with  inj. Clonidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block.

•Study site:  S.B.K.S. Medical Institute and Research Centre, Sumandeep Vidhyapeeth University, Piparia, Vadodara, Gujarat.

•Study duration: This study will be done for a periods of 18 months.

Study design:  comparative observational study

LIKELY OUTCOME / BENEFITS OF STUDY

This prospective and observational study will help us to compare the efficacy between Inj.  Bupivacaine and Inj Clonidine vs Inj Bupivacaine and Inj dexmedetomidine Improving the  duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some  provide sedation haemodynamic responses to anaesthesia by having better outcome in  haemodynamics.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient willing to sign inform consent.
  • ASA grade I and II patients posted for elective upper limb surgeries under Supraclavicular Brachial Plexus Block.

Exclusion Criteria

  • Patient refusal Infection at local site Hypersensitivity or Allergy to local anaesthetic agent Coagulation disorders Patient on Anticoagulants Alcoholic or patient with drug abuse Patients receiving any drug that interact with our study drug Pre Existing Nerve injury Inadequate effect of nerve block or supplemented with other type of anaesthesia.

Outcomes

Primary Outcomes

This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj Clonidine vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia

Time Frame: reversal of sensory and motor blockage and VAS score after giving blockage at following time point: | 0 min | 30 min | 1 hr | 2 hr | 3 hr | 4 hr | 5 hr | 7 hr | 10 hr

Secondary Outcomes

  • Analgesia and haemodynamic responses to anaesthesia by having better outcome in haemodynamics(At end of surgery)

Investigators

Sponsor
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Paresh M Chaudhary

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

Study Sites (1)

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