| CTRI Number |
CTRI/2025/11/097419 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of two techniques of brachial plexus block for anesthesia of arm in patients being operated for fracture humerus. |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided continuous
Interscalence block vs continuous Costoclavicular Brachial Plexus Block for Humerus Fractures in
obese patient. A single center randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupriya saxena |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Science |
| Address |
Department of Anesthesia
Government Institute of Medical Science.
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupriya saxena |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Science |
| Address |
Department of Anesthesia
Government Institute of Medical Science
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupriya saxena |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Science |
| Address |
Department of Anesthesia
Government Institute of Medical Science
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Science
Greater Noida
Uttar Pradesh 210312
India |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Science |
| Address |
Kasna
Greater Noida 210312
Uttar Pradesh
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anupriya saxena |
Government Institute of Medical Science |
Kasna
Greater Noida 210312
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
09953090044
anupriya.pmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M25||Other joint disorder, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continous costoclavicular brachial plexus block. |
Obese patients with humerus fracture will be given continous costoclavicular block for surgical anesthesia and followed thereafter for various block characterstics like onset of action, pain scores of the patient. |
| Intervention |
Continuous interscalene brachial plexus block. |
All obese patient having humerus fracture will be given continuous interscalne brachial plexus block for the surgerical anesthesia and followed thereafter to note the various characters of the block like onset of action, pain score of the patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA one, two , three ,
BMI more than equal to 25Kilogram per meter square having fracture of humerus scheduled for open reduction and internal fixation. |
|
| ExclusionCriteria |
| Details |
Refusal to participate, BMI less than 25 kiligram per meter square, pre-existing moderate-severe pulmonary disease (obstructive or restrictive), pre-existing neuropathy of the operative limb, coagulopathy, hepatic failure (Child-Turcotte-Pugh score more than 9) or renal failure (creatinine more than 2 milligram per decilitre or peritoneal di¬alysis or hemodialysis), infection at the puncture site, hypersensi¬tivity or allergy to LA, pregnancy, inability to communicate or cooperate and patients having chronic pain condition. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of continuous interscalene block and continuous costoclavicular block in obese patients undergoing surgery for humerus fracture. |
0 minute. 15minute,30 minute, 6 hours,12hours,18 hours, 24 hours , 36hours, 48hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Diaphragmatic excursion
2.Patient having any complications like Hoarseness, Dsypnoea Horners syndrome, PONV, Bradycardia ,Hypotension, Incidence of LAST, Pneumothorax
3.Accidental catheter dislodgement. |
0 minute. 15minute,30 minute, 6 hours,12hours,18 hours, 24 hours , 36hours, 48hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/11/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Multiple modes of anesthesia and analgesia, such
as general anesthesia (GA), interscalene blocks (ISBs), various brachial plexus
block approaches, and selective nerve blocks in combination with GA, have been
effective for upper limb fracture surgery. Identifying the optimal regional
anesthesia for these surgery is
essential for improving postoperative recovery. Interscalene blocks are a
standardized and reliable technique for anesthesia and postoperative analgesia
during humerus fracture surgery and are
many a times used as the sole means of anesthesia. [1]However, continuous ISBs
are associated with a relatively high risk of hemidiaphragmatic paralysis (HDP)
and are technically difficult in obese patients with short neck. Several other
brachial plexus blocks approaches distal
to the interscalene approach have been proposed such as the costoclavicular
block (CCB) .[2,3]This study focuses to evaluate the efficiency of this
costoclavicular approach of brachial plexus block in obese patients where
giving continuous interscalene block can be challenging. |