| CTRI Number |
CTRI/2024/05/067970 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the pain relief and occurrence of diaphragm (muscle of respiration) paralysis with two different techniques of blocking the nerves supplying sensation to the shoulder joint during shoulder surgeries. |
|
Scientific Title of Study
|
Comparison of combined suprascapular and axillary nerve block versus superior (upper) trunk block for phrenic nerve sparing analgesia in patients undergoing arthroscopic shoulder surgery A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/2024/5062 dated 08/04/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS, JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni,
Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
9414849733 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS, JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
9414849733 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Disha |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS JODHPUR. |
| Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
8708975749 |
| Fax |
|
| Email |
VANLIKA16U@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur. Rajasthan (INDIA) 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan (INDIA) 342005 |
| 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 |
| Dr Sadik Mohammed |
AIIMS JODHPUR |
Department of Anaesthesiology and Critical Care, 3rd Floor, DnT Block, AIIMS, Phase II, Basni Industrial Area, Jodhpur
RAJASTHAN Jodhpur RAJASTHAN |
9414849733
drmsadik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
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 |
GROUP SSN & AN (combined SSN and AN block) |
All patients will receive US-guided SSN and AN block with 20 mL 0.5% ropivacaine.
|
| Comparator Agent |
Group ST Superior Trunk Block |
All patients will receive ultrasound (US) guided ST block with 15 mL 0.5% ropivacaine.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18-60 years
2. Belonging to with ASA I/II/III category
3. Belonging to either sex,
4. Scheduled for unilateral shoulder orthopaedic surgery and providing consent for the procedure. |
|
| ExclusionCriteria |
| Details |
1. Pregnant female,
2. Patient with baseline cognitive deficits sufficient to make objective pain assessment unreliable,
3. Patients with coagulopathy, liver and renal dysfunction,
4. Preoperative neurological deficits and allergy to amide local anaesthetics.
5. BMI exceeding 30 kg/m2, mental disorders, chronic obstructive pulmonary disease or any respiratory ailment, coagulation disorders, prior trauma, neuropathy, myopathy, and the need for open surgery.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The composite primary outcome of the study will be the comparison of phrenic nerve sparing analgesia. Phrenic nerve sparing will be assessed as diaphragmatic excursion using ultrasound while the pain will be assessed both at rest and during movement using a numeric rating scale (NRS) |
From preoperative (Baseline) to first 24 hours postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of time to first rescue analgesia and total analgesic consumption. |
During the first 24 hours. |
| Comparison of pulmonary function (FVC, FEV1 & FEV1/FVC ratio) using portable spirometer. |
At baseline and at 30 mins after the procedure |
| Comparison of procedure-related complications if any in both groups. |
During first 24 hours in the postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients undergoing shoulder arthroscopic surgeries experience intense pain in the postoperative period that interferes with recovery and rehabilitation. Peripheral nerve blocks (PNBs) are the preferred choice to provide adequate intraoperative and postoperative analgesia. Among PNBs, the interscalene approach of the brachial plexus block (ISB) is considered to be the standard and the most commonly used block for shoulder surgeries. It provides good perioperative analgesia but is inevitably known to cause hemidiaphragmatic paralysis due to ipsilateral phrenic nerve blockade which can lead to respiratory distress, especially in patients with cardio-pulmonary compromise. The superior trunk (ST) block has been described as a refinement of the conventional ISB technique where LA is injected around the ST which is formed by fusion of C5 and C6 nerve roots. ST block produces non-inferior analgesia of the shoulder compared to ISB as all the nerves innervating the shoulder arise distal to the ST. Also, the site of injection is further away from the phrenic nerve theoretically reducing the risk of hemidiaphragmatic paresis. The major nerve supply of the shoulder joint arises from the suprascapular nerve (SSN) and axillary nerve (AN). Combined blockade of these two nerves has been shown to provide equivalent analgesia to ISB in shoulder surgeries with complete elimination of the risk of hemidiaphragmatic paresis. These two blocks i.e. ST block and combined SSN &AN block have not been compared for their phrenic nerve sparing analgesia. Therefore, we plan a study to compare these two block in terms of phrenic nerve sparing analgesia. The enrolled patients will be randomly divided into two groups by using a computer-generated random number table and the allocation concealment will be done by a sealed opaque envelope method that will be opened just before starting premedication. Group ‘ST’ (Superior Trunk Block)- All patients will receive ultrasound (US) guided ST block with 15 mL 0.5 percent ropivacaine. Group ‘SSN & AN’ (combined SSN and AN block)- All patients will receive US-guided SSN and AN block with 20 mL 0.5 percent ropivacaine. The outcome assessor/sonographer (assessing diaphragmatic excursion and NRS score) will be blinded to the group allocation. On the day of surgery, in the preoperative area, a blinded observer will perform a US examination to determine baseline diaphragmatic excursion. The baseline pulmonary function, including forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio will be assessed and recorded using a portable spirometer. 30 minutes after placement of the block, a repeat assessment of diaphragmatic excursion and IC will be performed and recorded. |