| CTRI Number |
CTRI/2024/10/075118 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Comparison of analgesic efficacy of superficial cervical plexus block versus clavipectoral fascia block for perioperative pain management in clavicular surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of superficial cervical plexus block versus clavipectoral fascia block for perioperative pain management in clavicular surgery |
| 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. Navya KS |
| Designation |
Junior Resident , Department of Anaesthesiology |
| Affiliation |
DR.D.Y.Patil Medical College,Hospital and Research Centre ,Pune |
| Address |
DR.D.Y.Patil Medical College, Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8073957296 |
| Fax |
|
| Email |
navyaks310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aparna Bagle |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
DR.D.Y.Patil Medical College, Hospital and Research Centre, Pune |
| Address |
DR.D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aparna Bagle |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
DR.D.Y.Patil Medical College, Hospital and Research Centre, Pune |
| Address |
DR.D.Y.Patil Medical College, Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.D.Y.Patil Medical College, Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India |
|
|
Primary Sponsor
|
| Name |
NAVYA KS |
| Address |
DR.D.Y.Patil Medical College, Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India |
| 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 Aparna Bagle |
DR.D.Y.Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
Department of Anaesthesia DR.D.Y.Patil Medical College, Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri,
Pune ,Maharashtra 411018
India
Pune
MAHARASHTRA |
9834430811
draparnabagle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTEE, Dr.D.Y.Patil Medical College,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M80-M85||Disorders of bone density and structure, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M843||Stress fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clavipectoral fascia block under ultrasound guidance |
After general anaesthesia, on the operative side clavipectoral fascia block with 15 ml of 0.25% bupivacaine hydrochloride will be given under ultrasound guidance for clavicular surgeries for perioperative pain management
|
| Intervention |
superficial cervical plexus block or clavipectoral fascia block |
In all patients posted for clavicular surgery, General anaesthesia will be given as per standard protocol. after General anaesthesia in one group Superficial cervical plexus block with 15 ml of 0.25% bupivacaine hydrochloride and in other group clavipectoral fascia block with 15 ml of 0.25% bupivacaine hydrochloride will be given under ultrasound guidance on the side of operation. |
| Comparator Agent |
Superficial cervical plexus block under ultrasound guidance |
After general anaesthesia, on the operative side Superficial cervical plexus Block with 15 ml of 0.25% bupivacaine hydrochloride under ultrasound guidance at the lateral border of sternocleidomastoid muscle at the level of cricothyroid cartilage will be given in clavicular surgeries for perioperative pain management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I or II fit patients.
2. Ages between 18 and 65 years
3. Patients undergoing clavicle surgeries.
4. Haemodynamically stable patients with all routine investigations within normal limits without any other co morbidities.
5. Patients who are not on any cardiac related drugs.
6. Availability of written informed consent from concerned patient.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in this study.
2. Patients with ASA physical status III and above physical status.
3. Patients less than 18 years and above 65 years of age.
4. Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal,
pulmonary disorders, hepatic disease with coagulation abnormalities etc.
5.Patients having local infection at the site where needle for block was to be inserted
6.Patients with bleeding or coagulation disorders.
7.Patients with known allergies to the study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of analgesic efficacy of superficial cervical plexus block versus clavipectoral fascia block for perioperative pain management in clavicular surgery by administration of Bupivacaine comparison between the two groups Post operative pain scores (VAS)and Time to first rescue analgesia will be assesssed.
|
After administration of the block ,comparison between the two groups of duration of analgesia, Post operative pain scores (VAS) at 8,12,16,20,24 hrs,Time to first rescue analgesia will be assesssed.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of analgesic efficacy of superficial cervical plexus block versus clavipectoral fascia block for perioperative pain management in clavicular surgery by perineural administration of Bupivacaine. |
After primary outcome comparison between the two groups of duration of analgesia & time to first rescue analgesia within 24 hr will also be assesssed.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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 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
|
Purpose of study is to compare duration of analgesic efficacy of Superficial cervical plexus block versus Clavipectoral fascia block for perioperative pain management in clavicular surgery . Hypothesis Clavipectoral fascia block have a equal analgesic efficacy as of Superficial cervical plexus block for clavicular surgery. |