CTRI

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CTRI Number

CTRI/2025/02/081240 [Registered on: 24/02/2025] Trial Registered Prospectively

Last Modified On:

21/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study comparing the effectiveness of two different doses of Dexmedetomidine combined with Levobupivacaine in supraclavicular brachial plexus block using peripheral nerve stimulator guidance

Scientific Title of Study

A comparative randomized double blind study of two different doses of Dexmedetomidine combined with Levobupivacaine in supraclavicular brachial plexus block under peripheral nerve stimulator guidance

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sunkesula Abdullah
Designation	Post graduate
Affiliation	Government medical college kadapa
Address	Government medical college putlampalli kadapa Cuddapah ANDHRA PRADESH 516003 India
Phone	9666782748
Fax
Email	abdullah.svmc.2k10@gmail.com

Details of Contact Person
Scientific Query

Name	Donthu Balaji
Designation	Associate professor
Affiliation	Government medical college kadapa
Address	Government medical college putlampalli kadapa Cuddapah ANDHRA PRADESH 516002 India
Phone	9505319721
Fax
Email	dr.balaji.donthu@gmail.com

Details of Contact Person
Public Query

Name	Donthu Balaji
Designation	Associate professor
Affiliation	Government medical college kadapa
Address	Government medical college putlampalli kadapa ANDHRA PRADESH 516002 India
Phone	9505319721
Fax
Email	dr.balaji.donthu@gmail.com

Source of Monetary or Material Support

Government medical college kadapa

Primary Sponsor

Name	Government medical college kadapa
Address	Government medical college putlampalli kadapa
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Sunkesula Abdullah	Government medical college kadapa	Government medical college putlampalli kadapa 516002 Cuddapah ANDHRA PRADESH	9666782748 abdullah.svmc.2k10@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Government medical college kadapa	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M00-M99\|\|Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M00-M99\|\|Diseases of the musculoskeletal system and connective tissue, (3) ICD-10 Condition: M00-M99\|\|Diseases of the musculoskeletal system and connective tissue,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Dexmedetomidine 50 microgram and 100 microgram	To compare efficacy of two different doses of dexmedetomidine 50mcg and 100mcg in supraclavicular brachial plexus block
Intervention	supraclavicular brachial plexus block	comparison of two doses of dexmedetomidine 50 mcg and 100 mcg in supraclavicular brachial plexus block under peripheral nerve stimulator guidance

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Age between 18 to 60 years ASA physical status I and II Patients scheduled for elective open reduction and internal fixation of fracture both bones forearm after obtaining written/informed consent from the patients

ExclusionCriteria

Details

Known allergy to local anaesthetic agents(known hypersensitivity to study drugs)
Traumatic nerve injury
History of respiratory disorders
History of neuromuscular diseases
History of cardiovascular diseases
Bleeding disorders or patients on anticoagulant therapy
Hepatic or renal failure
Pregnant and lactating women
Drug abusers and psychiatry patients

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To compare the duration of analgesia between the two groups	every 30 minutes up to 24 hours till block is completely worn off

Secondary Outcome

Outcome

TimePoints

To compare the onset of sensory and motor blockade between the two groups
To compare the duration of sensory and motor blockade between the two groups
To compare hemodynamic variables between the two groups
To compare the number of rescue analgesics in 24 hours in both groups
To compare adverse effects between the two groups

sensory and motor blockade was assessed every 2 minutes after completion of injection till 30 minutes later every 30 minutes after the completion of surgery till the first 12 hours and thereafter hourly until the block had completely worn off
Hemodynamics were recorded at 0 minutes 5 minutes 10 minutes 15 minutes 30 minutes 1 hour 2 hours 6 hours 12 hours and 24 hours
postoperative pain was assessed using VAS for every hour till the block lasted

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

05/03/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

A study titled A comparative randomized double blind study of two different doses of Dexmedetomidine combined with Levobupivacaine in supraclavicular brachial plexus block under peripheral nerve stimulator guidance was carried put in GMC KADAPA during the period from January 2023 to December 2023

This study included 100 patients randomly divided in to two groups of 50 patients in each group In group LD50 patients received 24ml of 0.5% Levobupivacaine combined with 50mcg of Dexmedetomidine diluted in 1ml of normal saline (total of 25ml) in supraclavicular brachial plexus block under peripheral nerve stimulator guidance where as in the other group Group LD100 patients received 24ml of 0.5% Levobupivacaine combined with 100mcg of Dexmedetomidine diluted in 1ml of normal saline (total of 25ml) in supraclavicular brachial plexus block under peripheral nerve stimulator guidance

Parameters such as onset of sensory and motor blockade duration of sensory and motor blockade duration of analgesia hemodynamics number of rescue analgesics in 24 hours sedation and adverse effects were noted

In this study significantly longer duration of analgesia was observed in Group LD100 when compared to Group LD50 A statistically significant faster onset and prolonged duration of sensorimotor blockade was observed in Group LD100 compared to LD50

Hemodynamic parameters including SBP DBP and MAP were found statistically significant from 5 minutes to 6 hours post administration of block in Group LD100 compared to group LD50 The number of rescue analgesics required in 24 hours was significantly higher in group LD50 when compared to group LD100

Incidence of adverse events like Bradycardia (HR<60bpm) Sedation score(>3) was significantly higher in group LD100 and they were manageable The incidence of hypotension (MAP<65mmHg) was comparable between two groups