CTRI

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CTRI Number

CTRI/2025/03/083420 [Registered on: 25/03/2025] Trial Registered Prospectively

Last Modified On:

21/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Single Injection vs. Intermittent Bolus Infraclavicular Brachial plexus Block for Post-Operative Pain After Distal Humerus Surgery

Scientific Title of Study

Comparative Evaluation of Post-operative Analgesic Efficacy of single injection with adjuvant versus intermittent bolus technique in infraclavicular brachial plexus block in patients undergoing surgery below distal humerus: A Prospective randomized observer blinded study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr Ganpat Prasad
Designation	Associate professor
Affiliation	Sanjay Gandhi Post graduate institute of medical science
Address	Dr Ganpat Prasad Associate professor Department of Anesthesiology SGPGIMS Lucknow Lucknow UTTAR PRADESH 226014 India
Phone	7905222941
Fax
Email	dr.prasadganpat@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rahul Kumar Mishra
Designation	Junior resident
Affiliation	Sanjay Gandhi Post graduate institute of medical sciences
Address	Room no.508 M1 Multistorey building MRA, SGPGIMS Lucknow UTTAR PRADESH 226014 India
Phone	9984921001
Fax
Email	rm126069@gmail.com

Details of Contact Person
Public Query

Name	Dr Ganpat Prasad
Designation	Associate professor
Affiliation	Sanjay Gandhi Post graduate institute of medical science
Address	Dr Ganpat Prasad Associate professor Department of Anesthesiology SGPGIMS Lucknow Lucknow UTTAR PRADESH 226014 India
Phone	7905222941
Fax
Email	dr.prasadganpat@gmail.com

Source of Monetary or Material Support

None

Primary Sponsor

Name	SGPGIMS LUCKNOW
Address	Department of Anesthesiology, Sanjay Gandhi Post graduate institute of medical science, Lucknow Uttar Pradesh 226014, India
Type of Sponsor	Research institution and hospital

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
Dr Ganpat Prasad	Sanjay Gandhi Post Graduate institute of Medical Sciences	Operation Theatre Complex First Floor Department of Anesthesiology Apex trauma centre Vrindavan Yojna Sector-17 Lucknow 226029 Lucknow UTTAR PRADESH	7905222941 dr.prasadganpat@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethical committee sanjay gandhi post graduate institute of medical sciences	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	single injection of 0.5% bupivacaine,25ml with 4mg dexamethasone in Infra clavicular brachial plexus block	Total fentanyl consumption till 48 hours in post operative patients undergoing surgery below distal humerus under infraclavicular brachial plexus block with single injection with adjuvant by use of Intra venous patient controlled analgesia
Comparator Agent	Single injection of 0.5% bupivacaine,25ml with catheter placement and through catheter 0.2% ropivacaine 15ml every 6hrly till 48hrs in infraclavicular brachial plexus	Total fentanyl consumption till 48 hours in post operative patients undergoing surgery below distal humerus under infraclavicular brachial plexus block with intermittent bolus technique by use of Intra venous patient controlled analgesia

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patient who will give written and informed consent Patient undergoing surgery below distal humerus. Patients belonging to ASA grade I and II.

ExclusionCriteria

Details

Patient refusal.
ASA grade III and IV
BMI 35 kg/m2
Patient with polytrauma
Patient who will have known allergy and intolerance to local anesthetics& having active skin infection.
Patient with cognitive impairment, delirium, dementia and severe hearing loss
Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anesthesia.
Patient having pre existing neurological deficit in forearm

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Total fentanyl consumption in 48 hrs after surgery by use of IV Patient Controlled Analgesia	48 hours

Secondary Outcome

Outcome	TimePoints
Static & dynamic pain assessment by Mean NRS (Numeric Rating Scale)at 2hr,4hr,12hr,18hr,24hr,30hr,36hr,42hr & 48hr till 48 hrs Patient satisfactory score at 48hrs Quality of recovery score at 48hrs Total rescue analgesia used in 48 hrs Post operative nausea & vomiting	48 hours

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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

N/A

Date of First Enrollment (India)

23/04/2025

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 Yet Recruiting

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

This study aims to compare the post-operative analgesic efficacy of single injection with adjuvant

versus intermittent bolus technique in infraclavicular brachial plexus block (ICB) for patients

undergoing surgery below the distal humerus. The advantages associated with the ICB like high

success rates, low complication risks, and adequate analgesia making it more preferable for upper

extremity surgery. The primary objective of the study is to compare total fentanyl consumption in

48 hours after surgery using IV Patient Controlled Analgesia and the secondary objective

comprises of static and dynamic pain assessment by Mean NRS till 48 hours, patient satisfactory

score, quality of recovery score, total rescue analgesia used in 48 hours, and postoperative nausea

and vomiting. Study design is a prospective randomized observer-blinded study, with patients

randomly allocated using block randomization. It will take place at Apex Trauma Center

SGPGIMS Lucknow, with a duration of 1.5 years for data collection. Inclusion criteria include

patients aged 18-70 years, ASA grade I and II, undergoing surgery below the distal humerus and

provided with informed and written consent. Exclusion criteria include ASA grade III and IV, BMI

> 35 kg/m2, polytrauma, known allergies to local anesthetics etc. Methodology followed in the

study involves preparing the patient, performing ultrasound-guided infraclavicular block, and

using specific equipment for local anesthetic administration. Patients in the single injection group

(SIG) will receive 25ml of (0.5% bupivacaine with 4mg of dexamethasone as an adjuvant), while

those in the intermittent bolus group (IBG) will receive 25ml of (0.5% bupivacaine). Patients in

both groups will receive postoperative analgesia via IV Patient Controlled Analgesia and 1gm

paracetamol every 6 hourlies as a part of multimodal analgesia for pain control. estimation of the

sample size will be based on reported fentanyl consumption in a similar study, with 40 patients

planned for each group. Statistical analysis will include comparing means/medians between groups

using various tests like t-tests or Mann-Whitney U tests for continuous variables and Chisquare/Fisher exact tests for categorical variables. Ethical considerations include obtaining

approval from the institutional ethics committee and written informed consent from patients. This

study will provide in depth information on the effectiveness of various ICB methods that may

improve postoperative pain management in patients undergoing surgery below the distal

humerus