| CTRI Number |
CTRI/2024/06/068720 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between two types of regional upper limb blocks specifically for unilateral clavicle fracture repair. |
|
Scientific Title of Study
|
Comparative study on the efficacy of ultrasound guided clavipectoral fascial plane block vs interscalene brachial plexus block combined with superficial cervical plexus block in clavicle surgeries - A randomized clinical 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 |
Dr. Unnithan Arya Gopinathan |
| Designation |
Junior resident PG 1 Anaesthesiology |
| Affiliation |
Shri B. M Patil Medical College Hospital and Research Centre |
| Address |
Department of anaesthesiology
B. L. D. E (Deemed to be university)
Shri B. M Patil Medical College Hospital and Research Centre,Vijayapura,586103, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9074261410 |
| Fax |
|
| Email |
dr.aryaunnithan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shivanand L Karigar |
| Designation |
Professor |
| Affiliation |
Shri B. M Patil Medical College Hospital and Research Centre |
| Address |
Department of anaesthesiology
B. L. D. E (Deemed to be university)
Shri B. M Patil Medical College Hospital and Research Centre,Vijayapura,586103, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Unnithan Arya Gopinathan |
| Designation |
Junior resident PG 1 Anaesthesiology |
| Affiliation |
Shri B. M Patil Medical College Hospital and Research Centre |
| Address |
Department of anaesthesiology
B. L. D. E (Deemed to be university)
Shri B. M Patil Medical College Hospital and Research Centre,Vijayapura,586103, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9074261410 |
| Fax |
|
| Email |
dr.aryaunnithan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College Bangaramma Sajjan Campus BLDE University, Vijayapura Karnataka 586103 |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College |
| Address |
Bangaramma Sajjan Campus, BLDE University, Vijayapura, Karnataka 586103 |
| Type of Sponsor |
Private 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 Unnithan Arya Gopinathan |
BLDE MEDICAL COLLEGE |
Department of Anaesthesia Solapur road Bangaramma Sajjan Campus Vijayapura
Bijapur
KARNATAKA |
9074261410
dr.aryaunnithan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil Medical College |
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 |
| Intervention |
Clavipectoral fascial plane block |
The patient will be supine with the head turned to the contralateral side. Under sterile aseptic conditions, a 6- to 13-MHz linear array probe will be used for regional anaesthesia. A local anesthetic solution of 20 mL 0.5% ropivacaine will be used. During C.P.B., using the in-plane technique, an ultrasound probe will be placed on both theinner and outer one-third of the anterior surface of the clavicle. A 22-gauge needle will be inserted and advanced into the space between the periosteum of the clavicle and clavipectoral fascia in a caudal to cephalad direction, and a total of 20 mL of 0.5% ropivacaine will be equally injected medially and laterally with the help of ultrasound landmarks and the in-plane needle path. |
| Intervention |
Interscalene brachial plexus block |
The patient will be supine with the head turned to the contralateral side under sterile aseptic conditions, and a 6- to 13-MHz linear array probe will be used for regional anaesthesia. To perform Interscalene brachial plexusblock,a high-frequency probe will be positioned at the level of the cricoid cartilage to visualize the brachial plexus between the anterior and middle scalene muscles. |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Superficial cervical plexus block |
The patient will be placed in a supine position and under all aseptic precautions, with the head turned to the contralateral side, for adequate exposure of the neck and the upper chest, a linear high-frequency ultrasound probe (6–13 MHz, Sonosite) will be placed at the lateral side of the neck over the midpoint of the sterno-cleidomastoid muscle at the level of the cricoid cartilage, which corresponds with the C6 transverse apophysis and its characteristic anterior tubercle. The superficial cervical plexus (S.C.P.) will be visualized just superficial to the prevertebral fascia overlying the interscalene groove. Using the posterior in-plane technique, a five cm block needle will be introduced from lateral to medial until its tip is placed near the S.C.P. above the prevertebral fascia. After careful negative aspiration to exclude intravascular placement, 7 mL of 0.5% ropivacaine will be deposited. |
| Intervention |
Ultrasound guided clavicle fracture regional block |
Ultrasound guided clavipectoral fascial plane block versus interscalene brachial plexus block combined with superficial cervical plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral clavicle fractures
Asa, grade 1 and 2
Elective internal fixation
Willing for proposed blocks |
|
| ExclusionCriteria |
| Details |
Cardio-cerebrovascular diseases( history of heart failure, poor control of hypertension, coronary heart disease and cerebrovascular history)
Respiratory insufficiency (more than 4 rib fractures,obstructive lung disease like emphysema, copd etc)
Abnormal blood coagulation
Puncture site infection
Allergy to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Superficial Cervical Plexus Block and Interscalene Brachial Plexus Block group as compared to Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block group using modified bromage scale |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score at 6 12 and 24 hrs after surgery is more in Superficial Cervical Plexus Block and Interscalene Brachial Plexus Block group as compared to Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block group |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized clinical trial type of study which compares efficacy of ultrasound guided clavipectoral fascial plane block versus interscalene brachial plexus block combined with superficial cervical plexus block in clavicle fractures. It consists total of 60 patients with 30 each in 2 groups namely "C" and "I". Group C will have Superficial cervical plexus block combined with Clavipectoral fascial plane block and group I includes superficial cervical plexus block combined with Interscalene brachial plexus block. Both groups will receive 20ml of 0.5% Ropivicaine without any adjuvants in patients posted for unilateral clavicle fractures surgeries using Sonosite ultrasound guidance. The study will be conducted in Shri BM Patil Medical College Hospital and Research Centre , Vijayapura, Karnataka in it’s Orthopedic OT complex. The primary objective is to asses the success rate of the block, ultrasonographic assessment of hemidiaghragmatic paresis by using sigh test and modified bromage scale to asses the upper limb function. The secondary objective is assessment of pain by using VAS score, time for first rescue analgesia, look for side effects including local anaesthetic systemic toxicity and Horner syndrome. |