| CTRI Number |
CTRI/2024/08/072176 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain relief in shoulder surgeries by giving injections around shoulder joint in different approaches |
|
Scientific Title of Study
|
Comparing Superior trunk of brachial plexus block and supraclavicular nerve block with shoulder pericapsular blocks and supraclavicular nerve block for post operative analgesia in patients undergoing shoulder arthroscopic surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Antrofelix M |
| Designation |
Post Graduate Registrar |
| Affiliation |
christian medical college |
| Address |
Department of anesthesiology, Christian Medical College, Vellore, Contact number: 9384355772
Vellore
TAMIL NADU
632004
India |
| Phone |
9384355772 |
| Fax |
|
| Email |
antrofelix666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul pillai |
| Designation |
Professor |
| Affiliation |
christian medical college |
| Address |
Department of anesthesiology, Christian Medical College, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9894460758 |
| Fax |
|
| Email |
cmcrahulpillai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Antrofelix M |
| Designation |
Post Graduate Registrar |
| Affiliation |
christian medical college |
| Address |
Department of anesthesiology, Christian Medical College, Vellore, Contact number: 9384355772
Vellore
TAMIL NADU
632004
India |
| Phone |
9384355772 |
| Fax |
|
| Email |
antrofelix666@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research Grant, Christian Medical College, Vellore- 632004, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Antrofelix M |
| Address |
Christian Medical College and Hospital, Vellore- 632004 |
| 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 Antrofelix M |
Christian medical College |
Department of Anaesthesiology, Christian medical College, vellore. Tamil nadu
Vellore
TAMIL NADU |
9384355772
antrofelix666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Review Board (Silver Ethics and Research Committee) of the Christian Medical College Vellore |
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 |
| Intervention |
shoulder pericapsular blocks and supraclavicular nerve block |
For the Shoulder anterior capsular block, patient in a lateral position and with the arm in extension. A high frequency linear ultrasound probe is placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a block needle is inserted using the ‘‘in plane’’ technique. When the needle passes through the deltoid muscle and touches the subscapularis tendon, a bone-like hard tissue is felt and the needle cannot be advanced further. The needle tip is placed between the deltoid muscle and subscapularis tendon, and 10ml of 0.2% ropivacaine is injected. For the shoulder posterior capsular injection, with the patient in lateral and arm in adduction, the posterior aspect of the shoulder is scanned using a high frequency linear ultrasound probe and the glenoid labrum and the humeral head are identified in the same ultrasound view, the needle is inserted in an in-plane technique between the infraspinatous muscle and the deltoid muscle and 10ml of 0.2% ropivacaine is injected within this plane. Along with this, the Supraclavicular nerves (SCN) are identified as small hypoechoic cluster, sandwiched between two layers of the deep cervical fascia enclosing the sternocleidomastoid (investing layer) and scalene muscles (prevertebral layer). The SCN cluster will be blocked with 5 ml of 0.2% Ropivacaine. The injection point will be chosen when the cluster appeared as a single group just lateral to the tapering edge of the sternocleidomastoid muscle. After that as is the standard protocol for shoulder surgeries, an ISB catheter will be placed but drug bolus will be given once the patient experiences pain score of more than 4 as assessed on the Visual Analogue pain assessment Scale (VAS). This VAS score monitored in serial interval for 36hours. |
| Comparator Agent |
Superior trunk of brachial plexus block and supraclavicular nerve block |
Patient in supine position, under strict aseptic precautions using high frequency linear ultrasound probe, the superior trunk is visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle is advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk where 5ml of 0.2% ropivacaine is given. Along with this, the Supraclavicular nerves (SCN) are identified as small hypoechoic cluster, sandwiched between two layers of the deep cervical fascia enclosing the sternocleidomastoid (investing layer) and scalene muscles (prevertebral layer). The SCN cluster will be blocked with 5 ml of 0.2% Ropivacaine. The injection point will be chosen when the cluster appeared as a single group just lateral to the tapering edge of the sternocleidomastoid muscle. After that as is the standard protocol for shoulder surgeries, an ISB catheter will be placed but drug bolus will be given once the patient experiences pain score of more than 4 as assessed on the Visual Analogue pain assessment Scale (VAS). This VAS score monitored in serial interval for 36hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II, III undergoing elective shoulder surgery. |
|
| ExclusionCriteria |
| Details |
ASAV IV, Patient refusal, Deranged coagulation profile, Local Anesthestic Allergy, Neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the postoperative pain scores between the two groups using Visual Analogue pain assessment Scale (VAS). |
36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the requirement of rescue analgesia, intraoperative hemodynamic stability, motor blockade. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Arthroscopic shoulder surgeries have the potential to cause severe postoperative pain. Poor pain management leads to poor outcomes, with longer hospital stay and delayed functional recovery. It also can cause an inability to participate in rehabilitation programs, leading to poor quality of life for the patients. Shoulder surgeries are amenable to either general anesthesia, regional anesthesia, or regional anesthesia with sedation. Opioid analgesics are commonly used for analgesia when nerve blocks are not used. Opioids are effective in relieving postoperative pain at rest but may increase post operative nausea and vomiting, somnolence, constipation, urinary retention, respiratory depression, and sleep disturbances. The interscalene brachial plexus block (ISB) has been reported to provide excellent post-operative analgesia but can produce side effects like phrenic nerve blockade resulting in diaphragmatic paresis causing respiratory distress to the patient. This necessitates the search for other nerve blocks which has similar analgesic efficacy as the ISB but without any associated complications. Injection around the superior trunk of the brachial plexus is an alternative technique that may reduce this risk. Along with supraclavicular block was suggested to provide effective anesthesia for shoulder surgery with a low rate of side-effects. The aim of this study is to compare the shoulder pericapsular blocks with superior trunk of brachial plexus block in relieving postoperative shoulder pain, intraoperative hemodynamic stability, avoiding motor block and allowing in early rehabilitation. Patients undergoing shoulder surgeries will be randomized into 2 groups as group A- will receive superior trunk of Brachial plexus block with supraclavicular nerve block. group B- will receive shoulder capsular blocks with supraclavicular nerve block |