| CTRI Number |
CTRI/2025/02/080450 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing pain relieving effect of a drug named ketorolac with local anaesthetic in upper limb nerve block for surgeries of upper limb fractures. |
|
Scientific Title of Study
|
A comparitive evaluation of analgesic efficacy of ketorolac as adjuvant with ropivacaine in ultrasound-guided supraclavicular nerve block in patients undergoing upper limb surgeries: A prospective randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushboo Pandey |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department Of Anaesthesia, AIIMS Rajkot, Khanderi-Parapilaiya, Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
9888530182 |
| Fax |
|
| Email |
khushboo0411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khushboo Pandey |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department Of Anaesthesia, AIIMS Rajkot, Khanderi-Parapilaiya, Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
9888530182 |
| Fax |
|
| Email |
khushboo0411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Saran |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department Of Anaesthesia, AIIMS Rajkot, Khanderi-Parapilaiya, Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
8422000468 |
| Fax |
|
| Email |
dranitasaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rajkot, Rajkot, Gujarat, India-360110 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
AIIMS Rajkot, Khanderi-Parapipaliya, Rajkot, Gujarat 360110 |
| 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 Khushboo Pandey |
AIIMS Rajkot |
OT-1, Ground floor OT Complex, IPD Building, AIIMS Rajkot, Khanderi-Parapipaliya, Rajkot
Rajkot
GUJARAT |
9888530182
khushboo0411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee AIIMS Rajkot |
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 |
| Comparator Agent |
Group C - Ketorolac will not be given through any route in this group |
Group C will receive supraclavicular block with injection ropivacaine 0.5% 20 ml with 1 ml of normal saline and 100 ml of normal saline will be given intravenously over 15 minutes. |
| Intervention |
Group KB - Ketorolac given perineurally through supraclavicular block |
Group KB will receive supraclavicular block with injection ropivacaine 0.5% 20 ml with ketorolac 1 ml (30 mg) and 100 ml of normal saline will be given intravenously (i.v.) over 15 minutes |
| Intervention |
Group KI - Ketorolac will be given intravenously |
Group KI will receive supraclavicular block with injection ropivacaine 0.5% 20 ml with 1 ml of normal saline; and 30 mg ketorolac will be administered i.v. in 100 ml of normal saline over 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1 and 2
2. BMI 20-30 kg/m-2
3. Patients scheduled for upper limb surgeries below the level of shoulder.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Coagulopathy
3. Patients with known allergy to local anaesthetics or NSAIDS
4. Patients with known neurological deficit involving brachial plexus
5. Patients with hepatic or renal or gastrointestinal dysfunction
6. Pregnant or lactating patient
7. Infection at local site
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Primary: Time to first rescue analgesic request |
At any poit of time between 0-24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Onset and duration of sensory and motor anaesthesia
b) VAS scores at rest and movement during 24 hours period
c) Haemodynamics and adverse effects (if any)
|
At 0min, 5min, 10min, 15min, 20min, 30min, 60min, 2hr, 4hr, 6hr, 12hr and 24hrs |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Ketorolac has been used perineurally to prolong analgesic duration in various peripheral nerve blocks. Ketorolac has also been widely utilized as systemic analgesic to combat moderate to severe pain administered through i.v. route. So far, there’s no evidence to compare the clinical efficacy of ketorolac as an adjuvant to ropivacaine in supraclavicular block when administered perineurally and intravenously. Therefore, we planned the current study to demonstrate the analgesic efficacy of ketorolac as adjuvant with ropivacaine in ultrasound-guided supraclavicular nerve block in patients undergoing upper limb surgeries. |