| CTRI Number |
CTRI/2023/06/054494 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients undergoing bankart shoulder surgery which of the following two methods,the ultrasound guided pericapsular nerve group block or ultrasound guided interscalene block gives better result for post operative pain relief |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided pericapsular nerve group block with ultrasound guided interscalene block for post operative analgesia in arthroscopic Bankart shoulder surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sureena Thapa |
| Designation |
Post Graduate 1st year |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9690772121 |
| Fax |
|
| Email |
sureenathapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Associate Professor |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Associate Professor |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahaveer Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhan Mahavir medical college and Safdarjung hospital |
| Address |
Safdarjung hospital Ansari Nagar new Delhi 110029 |
| 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 Sureena Thapa |
Safdarjung Hospital |
Department of anaesthesia vmmc Safdarjung Hospital New Delhi 110029
South
DELHI |
9690772121
sureenathapa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI , INSTITUTIONAL ETHICS COMMITTEE |
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 |
Comparison of ultrasound guided pericapsular nerve group block in shoulder with ultrasound guided interscalene block |
The two blocks are compared with respect of post operative analgesic efficacy,time of first rescue analgesia,total opioid requirements and patient satisfaction score |
| Intervention |
Ultrasound guided interscalene block |
45 patients,selected by randomisation,out of 90 patients, posted for Bankart shoulder surgery will be given ultrasound guided pericapsular nerve group block (of shoulder) for post operative analgesia and next 45 patients will be given ultrasound guided interscalene block. |
| Intervention |
Ultrasound guided pericapsular nerve group block of shoulder |
45 patients,selected by randomisation,out of 90 patients, posted for Bankart shoulder surgery will be given ultrasound guided pericapsular nerve group block (of shoulder) for post operative analgesia and next 45 patients will be given ultrasound guided interscalene block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patience with American Society of anaesthesiologist physical status grade 1 and grade 2 Aged 18 to 65 years undergoing elective arthroscopic Bankart shoulder surgery |
|
| ExclusionCriteria |
| Details |
1 Contraindication to nerve block coagulopathies/ on anticoagulant /local site infection and history of known allergy to local anaesthetics
2 Patient with known obstructive Airway disease patient with body mass index BMI more than or equal to 30 kg per metre cube
3 Patient who have cognitive disability and unable to understand NRS score |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative analgesic efficacy of ultrasound guided Pericapsular nerve group block with ultrasound guided interscalene block in patient undergoing arthroscopic bankart surgery using numerical ratings scale in first 24 hour in the post operative period |
Pre-block 30 minutes immediate postop 1st hrs postop 2nd hr postop 4th hr postop 6th hr postop 12th hr postop 24hr postop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the time of first rescue analgesia required in each group. |
First rescue analgesia |
To calculate the amount of additional rescue opioid analgesia required over 24 hours in each group
|
24 hr |
| To calculate the post operative patient satisfaction score in first 24 hours by using 5 point Likert scale. |
24hr |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/07/2023 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 14-06-2025 and end date provided 14-06-2026?
Response (Others) - Nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is an interventions randomized comparative study. We are comparing the analgesic efficacy of ultrasound guided pericapsular shoulder block with ultrasound guided interscalene block for arthroscopic Bankart shoulder surgery. The study aim to explore the benefits of pericapsular nerve group block, as the gold standard interscalene block has its own adverse effects.Patients will be assessed pre block, 3o min post block, immediately post op, at 1st hr,2nd hour,4th hour,6th hour ,12th hour and 24th hour. The comparison between the two groups will be done by Numerical Rating Scale. |