| CTRI Number |
CTRI/2026/03/106806 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare pain relief after shoulder surgery using a nerve block with ropivacaine alone versus ropivacaine with dexmedetomidine. |
|
Scientific Title of Study
|
A comparative study of efficacy of ultrasound guided interscalene brachial plexus block with 0.2% ropivacaine vs 0.2% ropivacaine with dexmedetomidine on postoperative analgesia in patients undergoing shoulder surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Rayala |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,PUNE,PIMPRI |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7993199894 |
| Fax |
|
| Email |
soumyarayala11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHILPA SARANG KORE |
| Designation |
Professor,department of Anaesthesiology |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,PUNE,PIMPRI |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHILPA SARANG KORE |
| Designation |
Professor,department of Anaesthesiology |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,PUNE,PIMPRI |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
RAYALA SOUMYA |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| 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 Soumya Rayala |
Dr.D.Y.Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
07993199894
soumyarayala11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics sub committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M759||Shoulder lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine |
9ml of 0.2% ropivacaine + 0.5 mcg/kg dexmedetomidine
(diluted with 0.9 % normal saline to 1 ml) |
| Intervention |
Ropivacaine |
9ml of 0.2% Ropivacaine with 1 ml of
NS was administered for ultrasound-guided IBPB |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Ages between 18 and 65 years
3. Patients undergoing upper shoulder surgeries under General anesthesia.
4. Hemodynamically stable patients with all routine investigations within normal limits .
5. Patients who are not on any cardiac related drugs.
6. Availability of written informed consent from concerned patient. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to get enrolled in this study.
2. Patients with ASA physical status III or more.
3. Patients below 18 years and above 65 years of age.
4. Patients posted for emergency procedures.
5. Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic
hypertension, pulmonary disorders, etc.
6. Patients with bleeding or coagulation disorders.
7. Patients with known allergies to the study drugs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of 0.2% ropivacaine versus 0.2% ropivacaine with dexmedetomidine in ultrasound guided interscalene brachial plexus block in patients undergoing shoulder surgeries |
After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time to rescue analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and at the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative analgesia between the two groups using pain scores & requirement of rescue analgesia |
Duration of analgesia will be assessed postoperatively once the effect of block wears off & time to rescue analgesia will be assessed at 2 hours after surgery & then hourly up to 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
11/04/2026 |
| 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
|
It is a prospective, randomized, double-blinded comparative study to evaluate the efficacy of dexmedetomidine as an adjuvant to 0.2% ropivacaine in ultrasound-guided interscalene brachial plexus block for postoperative analgesia in patients undergoing shoulder surgery. Parameters compared between the two groups will include duration of analgesia, onset and duration of sensory and motor block, postoperative pain scores (VAS), time to first rescue analgesia, sedation score, hemodynamic parameters, and incidence of adverse effects. |