| CTRI Number |
CTRI/2024/10/075804 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Two Doses of Intrathecal Clonidine as an Adjuvant to Hyperbaric Levobupivacaine for Enhanced Spinal Anesthesia in Femur Fracture Surgeries |
|
Scientific Title of Study
|
An Observational Study Of Comparison Of Two Different Doses Of Intrathecal Clonidine As Adjuvant With Hyperbaric levobupivacaine for subarachnoid blockage characteristics In Femur Fracture Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Jain |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7681960960 |
| Fax |
|
| Email |
radhujain27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jatin Patel |
| Designation |
Professor Of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jatin Patel |
| Designation |
Professor Of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat, 391760 |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodia, Piparia, Vadodara, Gujarat |
| 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 Jatin Patel |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT |
9879368363
dr_jatinpatel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
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 |
Hyperbaric Levobupivacaine and Clonidine
|
0.5% Hyperbaric Levobupivacaine 3mL with Clonidine 50 μg as single injection , intrathecal administration with total duration of 6.5 hours
|
| Intervention |
Hyperbaric Levobupivacaine and Clonidine |
0.5% Hyperbaric Levobupivacaine 3ml with Clonidine 30 µg as single injection , intrathecal administration with total duration 6 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to sign informed consent.
2. ASA I & ASA II patients undergoing spinal anaesthesia posted for Femur Fracture Surgeries.
3. Age between 18- 65 years.
4.No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Allergy to any drugs including test drug.
3. History of seizure disorder.
4. Patient taking clonidine or any other antihypertensives.
5. Patients with neurological disorders and neuropathies or receiving medications known to
influence neuromuscular junction.
6. ASA III, IV, Patients.
7. Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the sensory and motor blockage characteristics in spinal anaesthesia |
motor and sensory blockage characteristics assessed at 0,2,4,6,8,10 minutes then every 5 minutes upto 30 minutes and then every 15 minutes till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess Sedation Score, Duration of Absolute
Analgesia and Effective Analgesia, Number of
Rescue Analgesia required in 24 hrs and Complications if any.
|
Four Point Sedation Score will be assessed every 5 minutes for 15 minutes then every 15
minutes till the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="0"
Months="6"
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
|
Background Femur fractures are common injuries that often require surgical intervention, typically managed under spinal anesthesia. Hyperbaric levobupivacaine is widely used for its effective analgesic properties, but the addition of adjuvants can enhance its effects. Clonidine, an alpha-2 adrenergic agonist, has been shown to prolong anesthesia and improve analgesia when used in spinal anesthesia.
Purpose The purpose of this trial is to compare the effects of two different doses of intrathecal clonidine when used as an adjuvant to hyperbaric levobupivacaine in patients undergoing femur fracture surgeries. The study aims to assess differences in analgesic efficacy, onset and duration of sensory and motor block, and the incidence of side effects, ultimately guiding clinical practice in managing postoperative pain. |