| CTRI Number |
CTRI/2021/09/036529 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
14/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of two different drugs added to local anaesthetic drug given for spinal anaesthesia in patients undergoing orthopedic lower limb surgeries |
|
Scientific Title of Study
|
Comparison of intrathecal Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine in orthopedic lower limb surgeries- A double blind randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHRADDHA PATIL |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubballi |
| Address |
Dr Shraddha Patil
post graduate
Department of Anaesthesiology Karnataka Institute of Medical Sciences
Hubballi
Dharwad
KARNATAKA
580032
India |
| Phone |
9480779235 |
| Fax |
|
| Email |
shraddha.p77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma K S |
| Designation |
Associate proffessor |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubballi |
| Address |
Dr Sushma K S
Associate proffessor
Departmenr of Anaesthesiology Krnataka Institute of Medical Sciences
Hubballi
Dharwad
KARNATAKA
580032
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma K S |
| Designation |
Associate proffessor |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubballi |
| Address |
Dr Sushma K S
Associate proffessor
Departmenr of Anaesthesiology Krnataka Institute of Medical Sciences
Hubballi
Dharwad
KARNATAKA
580032
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences, Vidyanagar, Hubballi |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Patil |
| Address |
Post graduate
Department of Anaesthesiology
Karnataka Institute of Medical sciences, Vidyanagar, Hubballi |
| 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 Shraddha Patil |
Karnataka Institute of Medical Sciences, Hubballi |
Department of Anaesthesiology
Room No-206
Vidyanagar
Dharwad
KARNATAKA |
9480779235
shraddha.p77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, KIMS, Hubballi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (2) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (3) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
5 micrograms added intrathecally to 2.5 ml 0.5% Hyperbaric Bupivacaine |
| Comparator Agent |
Fentanyl |
25 micrograms added intrathecally to 2.5ml 0.5% Hyperbaric Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status 1 and 2
Patients giving informed valid written consent
Patients undergoing elective orthopedic lower limb surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients posted for emergency surgeries
Patients having uncontrolled hypertension or diabetes mellitus
Patients with renal or hepatic failure, cardiac block or dysrhythmia, coagulopathies, neurologic disorders
Patients having hypersensitivity to any of the study groups
Patients with known contraindications to spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeries |
after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare characteristics of block between 2 groups in view of
1.time from injection to highest sensory level
2.onset to bromage 3
3.time for sensory regression to S1 from higher sensory level
4. regression to bromage 0
5.time to rescue analgesia
6.numeric rating scale 6hrs after surgery
7.any adverse effects |
after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0, then after 6 hour asses about numeric rating scale |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 1 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A double blind randomized control study conducted to compare intrathecal dexmedetomidine and fentanyl as adjuvant to hyperbaric bupivacaine in orthopedic lower limb surgeries done under spinal anesthesia. 64 patients divided into 2 groups with 32 each, first group( group D) will receive 5mcg dexmedetomidine added to 2.5ml of 0.5% hyperbaric bupivacaine and next group( group F) will receive 25mcg fentanyl added to 2.5 ml of 0.5% hyperbaric bupivacaine intrathecally. Both sensory and motor status of patient will be assessed immediately after spinal injection, then every 2 minutes until reaching highest sensory level and Bromage scale 3. Then assessed every 10 minute till 2 segment sensory regression is seen. Then assessed every 20 minutes till sensory regression to S1 and Bromage 0. Severity of pain 2 and 4 hours after surgery will be measured by numeric rating scale(NRS). Time for 2 segment regression is more in group D than in group F patients We are also expecting longer duration sensory and motor blockade and longer post operative analgesia in group D patients
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