| CTRI Number |
CTRI/2025/10/095775 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Interscalene Block alone versus Interscalene Block combined with Superficial Cervical Plexus Block given for shoulder fracture patients under General Anaesthesia |
|
Scientific Title of Study
|
Efficacy of Interscalene Block versus Interscalene Block with Superficial Cervical Plexus Block for Proximal Humerus surgery under General Anaesthesia - a randomized Controlled double blinded Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUHAN |
| Designation |
Post Graduate in MD Anaesthesia |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
76B,Ananda Bhavanam,Dinamalar Nagar,Behind Pioneer Hospital,Ramanathapuram
Dept of Anaesthesiology,KIMS,KIIT university,Bhubaneshwar - 751024
Ramanathapuram
TAMIL NADU
623501
India |
| Phone |
9489735356 |
| Fax |
|
| Email |
guhannjp97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxman Senapati |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,3rd floor OT complex,KIMS,KIIT University,Patia,Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
7325919472 |
| Fax |
|
| Email |
meet.laxmans1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxman Senapati |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,3rd floor OT complex,KIMS,KIIT University,Patia,Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
7325919472 |
| Fax |
|
| Email |
meet.laxmans1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences,KIIT university,Patia,Bhubaneshwar - 751024, India |
|
|
Primary Sponsor
|
| Name |
Dr Guhan |
| Address |
Department of Anaesthesiology,3rd floor OT complex,KIMS,KIIT university,Patia,Bhubaneshwar |
| Type of Sponsor |
Other [Self] |
|
|
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 Guhan |
Kalinga Institute Of Medical Sciences |
Department of Anaesthesiology,3rd floor OT complex,KIMS,KIIT universify,Patia,Bhubaneshwar
Khordha
ORISSA |
9489735356
guhannjp97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Kalinga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of Interscalene Block versus Interscalene Block with Superficial Cervical Plexus Block for Proximal Humerus surgery under General Anaesthesia - A Randomized Controlled Trial |
Group 2 - Interscalene Block with 14ml of 0.25% Ropivacaine and Superficial Cervical Plexus Block with 10ml of 0.25% Ropivacaine |
| Intervention |
Efficacy of Interscalene Block versus Interscalene Block with Superficial Cervical Plexus Block for Proximal Humerus surgery under General Anaesthesia - A Randomized Controlled Trial |
Group I - Interscalene Block with 14ml of 0.25% Ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- American Society of Anaesthesiologists physical status (ASA) I
to III.
- Age 18-70 years.
- Patients scheduled to undergo elective surgery of the Proximal
Humerus Fracture under GA. |
|
| ExclusionCriteria |
| Details |
- Significant coagulopathy.
- Severe cardiac diseases.
- Severe renal diseases.
- Local site infection. |
|
|
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 assess 24hrs Opioid consumption in mg. |
To assess 24hrs Opioid consumption in mg. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Time to request of Rescue Analgesia in mins.
- Postoperative VAS score at 3,6,12 & 24 hrs postop.
- Local and systemic side effects (Inj site pain/infections)
- Patient satisfaction according to Likert’s scale |
3,6,12 and 24hrs postop |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2025 |
| 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="2"
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
|
Proximal humerus fractures are among the most prevalent fractures in adults, accounting for approximately 4–7% of all fractures. They are particularly common in older adults. The shoulder joint is predominantly innervated by the suprascapular nerve, axillary nerve (C5–6) and lateral pectoral nerves (C7). Part of the anterior surface of the shoulder is innervated by the supraclavicular nerve (C3–4). Therefore, blockade of the brachial plexus and the cervical plexus (IC block) is basically required.Interscalene block (ISB) might not cover the comprehensive dermatome distribution to provide adequate anaesthesia for patient undergoing proximal humeral fracture surgery, so addition of superficial cervical plexus block (SCPB) along with ISB will provide supplemental analgesia. In regard to the neuronal anatomy and clinical experience, the combined interscalene-cervical plexus block seems to be an effective block and may be a promising method for sufficient surgical anesthesia in clavicle surgeries ,but, there are no sufficient articles on same block comparison in Proximal Humerus Surgeries. Hence we will be conducting a Randomised Control Trial with the objective to assess the Analgesic efficacy of SCPB added with ISB for proximal humerus surgeries within the 2 study groups. |