| CTRI Number |
CTRI/2024/09/073570 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational study to assess the effect of ultrasound guided surficial cervical plexus block with clavipectoral fascial plane block or interscalene brachial plexus block in clavicle surgery |
|
Scientific Title of Study
|
The effect of ultrasound guided surficial cervical plexus block with clavipectoral fascial plane block or interscalene brachial plexus block in clavicle 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 |
Ganapathy S |
| Designation |
Post Graduate |
| Affiliation |
Shree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology Shree Balaji Medical College and Hospital Chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
8056542474 |
| Fax |
|
| Email |
ganapathy2537@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Vinod |
| Designation |
Professor |
| Affiliation |
Shree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology Shree Balaji Medical College and Hospital Chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Vinod |
| Designation |
Professor |
| Affiliation |
Shree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology Shree Balaji Medical College and Hospital Chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Balaji Medical College and hospital Chromepet Chennai600044 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Ganapathy S |
| Address |
Department of Anesthesiology Shree Balaji Medical College and Hospital Chromepet Chennai 600044 Tamilnadu 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 Ganapathy S |
Shree Balaji Medical College and Hospital |
Department of Anesthesiology
Chennai
TAMIL NADU |
8056542474
ganapathy2537@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Balaji Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient undergoing clavicle surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective surgery with ASA grade 1 and 2
2.Patient undergoing Elective surgery of Clavicular fracture Planned for ORIF plating of clavicle |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Abnormal blood coagulation
3.Allergy to local anesthesia
4.ASA grade III and above
5.Age more than 60 years and less than 18 years
6.Puncture site infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the time of first rescue analgesia in both the study group |
To find out the time of first rescue analgesia in 24housin both the study group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out pain score 2nd hour post operatively
To assess the Bromage score |
To find the VAS score 2nd hour post operatively for First 24 hours
To access the Upper limb Motor function in First 24 hours function |
|
|
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)
|
15/09/2024 |
| 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
|
1. Pre anesthetic checkup will be done before surgery 2. Procedure and possible complications of anesthesia and superficial cervical plexus block clavipectoral fascial plane block interscalene block will be explained in patients own language on the day before surgery during the review in the ward. Informed written consent will be obtained from the patient along with the witness signature. 3. On arrival to the operative room an IV access with 18 or 20 Gauge IV cannula will be secured. 4. Minimum mandatory monitoring of SpO2, BP, ECG, ETCO2, Temperature will be done. 5. As per the decision taken by the Consultant Anesthesiologist patients will receive either superficial cervical plexus block with clavipectoral fascial plane block or superficial cervical plexus block with interscalene block. 6. Group 1 Under sterile aseptic precautions superficial cervical plexus block 10ml of 0.5% Inj. Ropivacaine with clavipectoral fascial plane block 20ml of 0.5% Inj. Ropivacaine 7. Group 2 Under sterile aseptic precautions superficial cervical plexus block 10ml of 0.5% Inj. Ropivacaine with interscalene block 20ml of 0.5% Inj. Ropivacaine 8. Patient is handed over to the surgeon after assessing the effect of the block. If patient in either group complaints of pain, case is converted to General Anesthesia and is excluded from the study 9. In the recovery room and Post-operative ward the patients will be monitored for vital parameters which include BP HR SpO2 RR Effect of block measured at 30mins post operative analgesic duration motor function duration of block hemi-diaphragmatic paralysis. 10. Rescue analgesic will be administered as appropriate.
|