| CTRI Number |
CTRI/2022/04/041990 [Registered on: 20/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare effect of two nerve blocks PENG block around shoulder and Superior brachial trunk block in decreasing pain after arthroscopic shoulder surgeries. |
|
Scientific Title of Study
|
Comparison of Superior Brachial Trunk Block and Peri-capsular Nerve Group Block of Shoulder Joint in Arthroscopic Shoulder
surgery: A Randomized Non-Inferiority Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dadi Uma Gowri Sankar |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi
South DELHI 110029 India |
| Phone |
9581665158 |
| Fax |
|
| Email |
dadiumagowrisankar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bikash Ranjan Ray |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi
South DELHI 110029 India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bikash Ranjan Ray |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi
South DELHI 110029 India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, pain medicine and Critical care, All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dadi Uma Gowri Sankar |
All India Institute of Medical Sciences |
Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care South DELHI |
9581665158
dadiumagowrisankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular Nerve Group (PENG) block around shoulder joint |
15 ml of 0.5% ropivacaine will be injected between subscapularis
tendon below and deltoid muscle above under ultrasound guidance followed by post operative follow up with pca pump for 24 hrs |
| Comparator Agent |
Superior brachial trunk block |
15ml of 0.5% ropivacaine will be injected around superior trunk of brachial plexus under ultrasound guidance followed by post operative follow up with pca pump for 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA I to III patients.
2) Age group of 18-80
3) Scheduled for elective unilateral arthroscopic
surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients who refused to participate in the study.
2. Patients with a history of cardiac, renal, or hepatic disease
3. Patients with Pre-existing neurologic deficits or neuropathy affecting the brachial plexus
4. Patients with Contraindications to peripheral nerve block
5. Patients with known allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Cumulative opioid
consumption at 24hrs, after arthroscopic shoulder surgery
between superior brachial trunk block and PENG block around shoulder with a prespecified non inferiority level of 15%. |
24hrs after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the two groups the following parameters:
1) 24hr pain intensity on an 11-point numerical rating score
2) Time for first analgesic requirement
3) Motor blockade
4) Patient satisfaction with pain relief at 24hrs
5) Surgeon Satisfaction
6) Diaphragmatic Excursion
7) complications |
During intra operative period and 24hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2022 |
| Date of Study Completion (India) |
23/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient’s recovery, hence regional anaesthesia plays an important role in decreasing the pain following shoulder surgeries. Superior Brachial trunk block a variant of conventional interscalene block is found to be non inferior to latter in providing adequate post operative analgesia. However superior brachial trunk block like interscalene block is associated with incidence of hemi diaphragmatic paresis due to local anaesthetic spread around the phrenic nerve. PENG block around shoulder joint is a new motor sparing block that causes only sensory blockade that needs to be evaluated. Standard Pre-Anesthetic Check Up will be done preoperatively and no premedication will be given. Informed and written consent will be taken from the patients while educating them about PCA machine and 11-points numerical rating scale for pain. When the patient arrives pre-op holding area: Baseline ipsilateral dome Diaphragmatic Ultrasound (T1) will be done for diaphragmatic excursion. Patient is randomly allocated via a sealed envelope to get either a superior brachial trunk block or PENG block around shoulder. In the operating room: standard monitoring will be done (HR, RR, NIBP, SpO2, EtCo2). Depending on the group to which the patient will be allocate either superior brachial trunk block or PENG block around shoulder will be given. Under aseptic conditions high frequency linear transducer will be placed over the interscalene region and superior brachial trunk block will be carried out For patients allocated to PENG block round shoulder group, high frequency linear transducer will be placed longitudinally between coracoid process and head of humerus and drug will be injected between subscapularis tendon below and deltoid muscle above. Drug to be used: 0.5% ropivacaine 15ml in both the blocks. Drug injected time will be taken as T0. At T20 motor blockade will be assessed. Patient will be induced with fentanyl 2mcg/kg, propofol 1.5 – 2 mg/kg, atracurium 0.5mg/kg followed by tracheal intubation. Maintenance: sevoflurane with air and oxygen. Intra operatively bolus of fentanyl 0.5mcg/kg will be given if heart rate and blood pressure increase by > 20% of baseline. Complications if any will be managed as per standard protocol. At the end of surgery reversal will be done with neostigmine and glycopyrrolate followed by extubation, and the patient will be shifted to PACU. Post operatively: USG will be done to find out diaphragmatic excursion. PCA pump will be attached to the patient that delivers 25mcg of fentanyl on demand with a lockout interval of 15 mins, with no basal dose. Inj PCM 10-15 mg/kg 6 hourly will be supplemented and injection ketorolac 0.5mg/kg iv 12 hourly as a part of multimodal analgesia, and if patient complains of pain more than 4/10 on VAS then 75-100 mcg/kg of morphine will be given. After 24 hrs. PCA pump will be disconnected and total fentanyl consumed will be noted. In addition, rescue opioids given if any are also noted, pain according to VAS from 0 – 10 is noted, patient satisfaction, surgeon satisfaction and complications if any will be noted down. The collected data will be analyzed using SPSS 20.1 (IBM Corp). Parametric variables will be described as mean ± standard deviation and qualitative variables were described as number (percentage) and as median and range. |