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Clinical Trials/CTRI/2025/08/092384
CTRI/2025/08/092384Not yet recruitingNot Applicable

Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 site in 1 country60 target enrollmentStarted: August 28, 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 dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation

Study Overview

Brief Summary

Subject: “Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular

Brachial Plexus Block”

AIM: To Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block”

OBJECTIVES

1.To observe and compare Onset and duration of sensory and motor block

2.To observe and compare Duration of analgesia

3.To compare Perioperative hemodynamic changes & any adverse effects

MATERIAL AND METHODOLOGY

This will be a comparative double blinded randomized observational study in which after approval from institutional review board and informed written consent from the patient, study will be started.

All patients will be subjected to detailed pre anaesthetic evaluation with clinical history, general and systemic examination and all routine investigations like hemoglobin, RBS, RFT, LFT, serum electrolytes, X-ray, ECG and other specific investigations according to the patient’s clinical evaluation. Patients will be advised to keep NBM before Operation.

Pre-Operative vitals will be recorded.

An IV infusion of Ringer Lactate /Normal Saline will be started.

Study Design- randomized double blinded Study

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by whichever is earlier.

Sample size:60s,2 group each divided in 30s

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. dexomethasone (8mg) through PNS or USG machine guided supraclavicular block.

OBSERVATIONS :

  1. OnsetofSensoryBlock

  2. DurationofSensoryBlock

  3. OnsetofMotorBlock

  4. DurationofMotorBlock

  5. DurationofAnalgesia:TimefromOnsetofsensoryblocktoneedforfirstrescueanalgesia.

  6. Hemodynamic Parameters

  7. SedationScore

  8. PerioperativeComplications

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

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.

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 dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation

Time Frame: This prospective and observational study will help us to compare the efficacy between inj Bupivacaine and Inj dexomethasone 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 haemodynemics at baseline and fifteen minutes after inductuin up to one hour and than one hourly up to twenty four hours after surgery

Secondary Outcomes

  • Analgesia & haemodynamic responses to anaesthesia by having better outcome in haemodynemic(Twenty four hours after induction of local anaesthesia after 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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