| CTRI Number |
CTRI/2026/01/101488 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief comparison between two nerve block in patients undergoing arthroscopic shoulder surgery under general Anaesthesia |
|
Scientific Title of Study
|
Comparison of high thoracic erector spinae plane block with suprascapular nerve block for postoperative analgesia in arthroscopic shoulder surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rabadiya Yashkumar Jaysukhbhai |
| Designation |
Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Ot complex 2nd floor Department of Anaesthesia Mahatma Gandhi Medical college And Hospital, Sitapura, Jaipur , Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7778045025 |
| Fax |
|
| Email |
yash.rabadiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana verma |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Ot complex 2nd floor Department of Anaesthesia Mahatma Gandhi Medical college And Hospital, Sitapura, Jaipur , Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7727886029 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana verma |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Ot complex 2nd floor Department of Anaesthesia Mahatma Gandhi Medical college And Hospital, Sitapura, Jaipur , Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7727886029 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi hospital sitapura jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of anaesthesia and critical care, Mahatma Gandhi hospital, sitapura, Jaipur (302022), Rajasthan, India |
| Type of Sponsor |
Private 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 Rabadiya Yashkumar Jaysukhbhai |
Mahatma Gandhi Hospital |
OT compl 2nd floor Department of Anaesthesia, Mahatma Gandhi hospital, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
7778045025
yash.rabadiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC for Biomedical and Health Research as per National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Thoracic Erector Spinae Plane Block (T2 level) |
A total of 86 consenting patients fulfilling inclusion criteria and undergoing arthroscopic shoulder surgery under general anaesthesia will be enrolled in the study period.
Patients will be randomly allocated into two groups of 43 patients each using a box/randomization method.
Group I (ESPB Group):
Patients will receive ultrasound-guided high thoracic erector spinae plane block at T2 level using local anaesthetic drug as per protocol, administered 30 minutes before surgery.
Postoperative pain will be assessed using Numerical Rating Scale (NRS) at:
Recovery (0 hour), 4, 8, 12, and 24 hours postoperatively
Rescue analgesia will be provided as per institutional protocol when NRS 4.
|
| Comparator Agent |
Supra-scapular Nerve Block |
A total of 86 consenting patients fulfilling inclusion criteria and undergoing arthroscopic shoulder surgery under general anaesthesia will be enrolled in the study period.
Patients will be randomly allocated into two groups of 43 patients each using a box/randomization method.
Group II (SSNB Group):
43 Patients will receive ultrasound-guided supra-scapular nerve block using local anaesthetic drug as per protocol, administered 30 minutes before surgery.
Route of administration: Local infiltration under ultrasound guidance
Postoperative pain will be assessed using Numerical Rating Scale (NRS) at:
Recovery (0 hour), 4, 8, 12, and 24 hours postoperatively
Rescue analgesia will be provided as per institutional protocol when NRS 4. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Arthroscopic shoulder surgeries under General Anesthesia
2. Age: 18 to 65 years
3. All genders
4. ASA Physical status 1 or 2
5. BMI less than 35kg per meter square
|
|
| ExclusionCriteria |
| Details |
1. History of Drug Allergy
2. Any bleeding disorder or patient on any anticoagulants.
3. Local infection at block site
4. Chronic opioid use
5. History of cervical/thoracic spine surgery
6. Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of postoperative analgesia with NRS Scale (Numeric Rating Scale) |
Postoperative pain scores will be assessed using Numeric Rating scale for 24 hours post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess time to first rescue analgesia
To compare postoperative opioid consumption in both groups.
To assess patient satisfaction scores.
To evaluate incidence of block-related complications.
|
Assessments will be done at Recovery (0 hour), 4, 8, 12, and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
01/02/2027 |
| 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 - NO
|
|
Brief Summary
|
Arthroscopic shoulder surgery is commonly associated with significant postoperative pain, which can delay early mobilization and recovery. Various regional anaesthesia techniques have been employed to improve postoperative analgesia and reduce opioid consumption. Suprascapular nerve block is a commonly used regional technique for shoulder surgeries, whereas high thoracic erector spinae plane block has recently emerged as an effective alternative providing wide dermatomal analgesia. Ultrasound guidance has improved the accuracy and safety of peripheral nerve blocks, allowing precise deposition of local anaesthetic and reducing complications. The erector spinae plane block, performed at the second thoracic vertebral level, may provide effective analgesia to the shoulder region by spread to the dorsal and ventral rami. This randomized, double-blinded clinical study aims to compare the analgesic efficacy of ultrasound-guided high thoracic erector spinae plane block with suprascapular nerve block in patients undergoing arthroscopic shoulder surgery, with respect to postoperative pain scores, duration of analgesia, and rescue analgesic requirements. |