| CTRI Number |
CTRI/2023/05/052173 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of post operative pain relief of two different drugs fentanyl and dexmeditomidine as a supplement with bupivacaine in spinal anaesthesia in lower limb ilizarove(reconstructive) surgery. |
|
Scientific Title of Study
|
Comparative study of analgesic effect of intrathecal administration of dexmeditomidine and fentanyl as adjuvants to bupivacaine in lower limb Ilizarov surgeries.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Desai |
| Designation |
Associate professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Plot no 186, "RUDRA",Greencity, Near Faldu vadi , Chobari road, Junagadh.
GMERS Medical College And Hospital Junagadh,near majevadi gate, paddok road, Junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
|
| Fax |
|
| Email |
drdiptivasani50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Desai |
| Designation |
Associate professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Plot no 186, "RUDRA",Greencity, Near Faldu vadi , Chobari road, Junagadh.
GMERS Medical College And Hospital Junagadh,near majevadi gate, paddok road, Junagadh.
GUJARAT
362001
India |
| Phone |
|
| Fax |
|
| Email |
drdiptivasani50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipti Desai |
| Designation |
Associate professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Plot no 186, "RUDRA",Greencity, Near Faldu vadi , Chobari road, Junagadh.
GMERS Medical College And Hospital Junagadh,near majevadi gate, paddok road, Junagadh.
GUJARAT
362001
India |
| Phone |
|
| Fax |
|
| Email |
drdiptivasani50@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College, Paddock Road,Near Majevadi Gate, Junagadh, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Dr Dipti Desai |
| Address |
Plot no 186,"RUDRA", Greencity, Near Faldu vadi, Chobari road Junagadh. |
| 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 Dipti Desai |
Orthopaedic Operation Theatre |
Block No. 307, Orthopaedic Operation Theatre, GMERS Medical College And Hospital, Junagadh, Near Majevadi gate, paddok road, Junagadh.
Junagadh
GUJARAT |
9924458855
drdiptivasani50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, GMERS Medical College,Junagadh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmeditomidine |
In this group of patients, bupivacaine 15mg(3ml) + dexmeditomidine 5mcg will be given. |
| Intervention |
Fentanyl |
In this group of patients, bupivacaine 15mg (3ml)+ fentanyl 25mcg will be given. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patient posted for femur/tibia ilizarove surgery for deformity correction,treatment of nonunion,ilizarov in open fracture under spinal anaesthesia only.
2 patient giving verbal conscent.
3 asa 1,2 and 3.
4 both elective and emergency surgery unless contraindicated. |
|
| ExclusionCriteria |
| Details |
1 Patients with poor GCS,
2 Patients with renal and liver diseases,
3 Patients with bleeding tendencies and coagulopathy,
4 Patients with known neuropathy,
5 Patients with skin lesions at local site, 6 Patients with local anesthetic allergy,
7 Patients requiring general anaesthesia |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of efficacy of both drugs |
2hr,4 hr,6hr, 8hr, 10hr,14hr,18hr and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare safety and haemodynamic stability of both drugs |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized ,double blind ,parellel group, controlled trial comparing the safety and
efficacy of intrathecal administration of fentanyl and dexmeditomidine as an adjuvant to bupivacaine in 60 patients undergoing ilizarove surgery in lower limb. |