| CTRI Number |
CTRI/2025/07/091305 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing efficacy of two combination blocks in patients undergoing surgery for fixation of fracture clavicle |
|
Scientific Title of Study
|
A COMPARATIVE EFFICACY
OF ULTRASOUND GUIDED
INTERSCALENE BRACHIAL
PLEXUS BLOCK COMBINED
WITH SUPERFICIAL CERVICAL
PLEXUS BLOCK VERSUS
CLA VIPECTORAL FASCIA
PLANE BLOCK COMBINED
SUPERFICIAL CERVICAL
FLEXUS BLOCK IN PATIENTS
UNDERGOING FIXATION OF
FRACTURE CLAVICLE: A
RANDOMIZED CONTROLLED
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 |
Sushma J Ayli |
| Designation |
Postgraduation |
| Affiliation |
Ballari Medical college and research centre ,Ballari |
| Address |
Sushma J Ayli
Department of Anaesthesia
Cantonment,
Ballari Medical college and Research centre,Ballari.
Bellary KARNATAKA 583101 India |
| Phone |
9108717609 |
| Fax |
|
| Email |
aylisushma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrBala Subramanya H |
| Designation |
Professor |
| Affiliation |
Ballari Medical college and research centre ,Ballari |
| Address |
Department of Anaesthesia
Cantonment,
Ballari Medical college and Research centre,Ballari
Bellary KARNATAKA 583101 India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrBala Subramanya H |
| Designation |
Professor |
| Affiliation |
Ballari Medical college and research centre ,Ballari |
| Address |
Department of Anaesthesia
Cantonment,
Ballari Medical college and Research centre,Ballari
Bellary KARNATAKA 583101 India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Trauma care centre,BMCRC Ballari |
|
|
Primary Sponsor
|
| Name |
Ballari Medical College and Research Centre,Ballari |
| Address |
Cantonment
Ballari
Karntaka State
Pin 583104 |
| 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 Sushma J Ayli |
Ballari Medical College and Research Centre |
Department of Anaesthesiology,
BMCRC, Ballari
Bellary KARNATAKA |
9108717609
aylisushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,BMCRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: S420||Fracture of clavicle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: Patients will receive interscalene brachia! plexus block (ISB) combined with
superficial cervical plexus block (SCPB)
Group B: Patients will receive clavipectoral facia plane block and superficial cervical plexus block |
Study drug is prepared by adding 22.5 mL of 0.5% bupivacaine with 7.5 mL of sterile water
to obtain a concentration of0.375% ofbupivacaine. Ultrasound guided block(USG) will be
performed as per the group by an anaesthetist having
experience
of performing
at least
50 ultrasoung guided blocks.Sono site® ultrasound machine with 8-13 MHZ linear probe
will be used to perform the blocks.
. The randomisation is done
using the randomization number obtained from the website www.randomization.org. Group allocation concealment is
done by sequentially numbered sealed opaque sealed envelope (SNOSE) technique . Patient
will be withdrawn from the study in case of failure or patchy block, and general anaesthesia
will be given for the completion of the case. The intra-operative and post-operative
assessments of patients and data recording will be carried out by another Anaesthesiologist
who is blinded to the technique of USG guided nerve block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Any patient with unilateral fracture clavicle undergoing surgery for elective fixation.
2 Patient belonging to ASA 1-II physical status
3 Patients of either sex in the age group of 18 -65 years |
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 Patient with allergy to local anaesthetic agents
3 Patient with pre-ex.isting injury to brachial plexus
4 Patient with coagulopathies or bleeding disorder
5 Patient with infection al the site of block
• Patients on any steroids or on long term analgesics
• Patient with severe systemic disorder
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia in two groups |
Immediate post op, 30 min,1 hr , 2 hr ,3 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Onset of sensory blockade over clavicle
-Upper limb weakness
-Total requirement of analgesics in first 24hrs
-Assessment of pain at various intervals by NRS pain score.
-Diaphragmatic movement
-Complications if any
|
Intra operative and post operative |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6" 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
|
Title: A comparative efficacy of ultrasound guided interscalene brachia! plexus block combined with superficial cervical plexus block versus clavipectoral fascia plane block combined superficial cervical flexus block in patients undergoing fixation of fracture clavicle: A randomized controlled trial Need for Study / Introduction Clavicular fracture is the most common injury in the shoulder, particularly in young men. It mainly occurs due to sports or road traffic accidents, especially in the middle of the clavicle. Better functional results can be obtained by surgical fixation of the fracture. Exact innervation of clavicle is debatable 1• The supraclavicular nerve of the superficial cervical plexus is responsible for innervation of the bone and skin above the clavicle, while the brachial plexus innervates the deep muscle of the clavicle. Regional anaesthesia carri es several advantages over general anaesthesia. lnterscalene brachial plexus block in combination with superficial cervical plexus block is commonly used anaesthetic technique for the surgical fixation of fracture clavicle. General anaesthesia is the other option but carries inherent risk of polypharmacy,airway trauma and neuroendocrine stress response to intubation.
Clavipectoral fascia! plane block(CPB) is a new regional nerve block proposed by Valdes in 2017 where in local anaesthetic agents are injected into clavipectoral fascia plane which can be used for anaesthesia and postoperative analgesia in patients undergoing surgery for fracture clavicle. It provides effective pain control for procedures involving the midshaft and lateral clavicle. This typically avoids phrenic nerve blockade, thus preserving diaphragmatic function • It also minimizes unnecessary numbness or motor block in adjacent regions. It is easily visualized with ultrasound, which enhances precision and safety of this block. This block can be performed in combination with other regional techniques (e.g., superficial cervical plexus block) for broader cove rage. There are very few studies comparing the efficacy of clavipectoral block with the commonly used inter scalene brachial plexus block in combination with superficial cervical plexus for fixation of fracture clavicle. Hence this study is conducted to explore the comparative efficacy of this block. Review of Literature 1. Guangmin Xu, et al. (2017)3 in a randomized controlled trial compared US guided superficial cervical plexus block with clavipectoral fascia! plane block or interscalene brachial plexus block in 50 patients who underwent elective internal fixation of fracture clavicle. The effects of the block measured at 30 min of both regional anaesthesia were very satisfactory. Compared with ultrasound-guided SCPB and ISBP, SCPB combined with CPB for clavicular operation has longer postoperative analgesia, better preserves the motor function of the upper limbs and avoids the incidence of diaphragmatic paralysis. Therefore, this technique is suitable for application in clinical practice. 2. Olofsson M., ct al (2020)4 in a matched case- controlled study done on 50 consecutive patients who underwent surgical fixation of clavicle. All patients received lnterscalene brachial plexus block for surgical repair of clavicle fracture .The study concluded that there is significant lower consumption of iv morphine in the whole cohort. 3_ Kukrc.ia P, ct al. (2020t in a case series on ultrasound-guided Clavipectoral Fascia! Plane Block for Surgery involving the Clavicle in 3 patients found that the CPB is another effective alternate anaesthesia technique while avoiding undesirable side effects of more proximal techniques such as motor blockade or phrenic nerve paralysis. Moreover, it does not carry any risk of pneumothorax. The technique is easy to perform and has an advanced safety profile, especially for patients with respiratory disease. Compared with other brachial plexus blocks which prevent pain transmission more proximally, CPB offers more distal blockade and superficially. This case series adds up to evidence supporting the utility of CPB. 4. Faramarz Mosaffa, et al (2023)6 in a randomized double-blinded, non-inferiority clinical trial on 120 patients compared interscalene block (ISB) with or without superficial cervical plexus block (SCPB) for anaesthesia in clavicle surgery. The primary outcome was defined as the conversion to GA. Various factors were recorded, including surgery duration, nerve block initiation, analgesics required in the post anaesthesia care unit (PACU), and sedation during surgery. Efficacy of ISB is the same whether or not it is combined with a SCPB. lnterscalene block is an alternative regional anaesthesia approach for clavicle fractures. Thus, ISB alone is as efficient as when used in combination with SCPB.
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