| CTRI Number |
CTRI/2025/11/097955 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of pain after nerve block wears off in patients undergoing arthroscopic shoulder surgeries. |
|
Scientific Title of Study
|
Rebound pain in patients undergoing orthopedic shoulder surgeries under interscalene block with general anesthesia: An observational study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Genevieve Dmello |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anesthesiology
Kasturba Medical college
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9480014695 |
| Fax |
|
| Email |
priya.dmelo90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Genevieve Dmello |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anesthesiology
Kasturba Medical college
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9480014695 |
| Fax |
|
| Email |
priya.dmelo90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savan Kumar |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anesthesiology
Kasturba medical college
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8105308865 |
| Fax |
|
| Email |
savan.nagesh@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priya G Dmello |
| Address |
Department of Anesthesiology
KMC
Manipal
Udupi |
| Type of Sponsor |
Other [Priya G Dmello] |
|
|
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 |
| Priya Dmello |
Kasturba Medical College |
Operation theater(orthopedic),
Department of Anesthesiology,KMC,
Manipal, Udupi 576104
Udupi
KARNATAKA |
9480014695
priya.demello@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2 and 3
Arthroscopic shoulder repair, rotator cuff tears, Bankarts repair requiring interscalene block and general
anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients who are on strong opioids (morphine, fentanyl, nalbuphine, buprenorphine) or more than 2
analgesics in the preoperative period.
Patients who are contraindicated for interscalene block.
Not able to comprehend the VAS scoring system.
Failed block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. incidence of rebound pain
|
before the nerve block
postoperatively if NRS score more than 3; then a 24 hour recall of when pain was severe will be recorded on NRS scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictors of rebound pain. |
at 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2025 |
| 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
|
The patients undergoing arthroscopic shoulder surgery under interscalene and general anesthesia will be recruited. The patients will be screened for eligibility on the day prior to surgery for consent and for a baseline NRS pain score. After the surgery the patient will be shifted to the postoperative room where the patient who have a pain score of less than 3 will be recruited which will be considered as a successful interscalene block. The patients will be given analgesics over timely periods as per the departmental protocol over the next 24 hours. The patient will be asked to recall the first time at which the pain was unbearable and to score it in the first 24 hour period. Additional analgesics given to the patient will be recorded. It is a time bound study over a period of 1 year recruiting only those patients requiring shoulder arthroscopy. |