| CTRI Number |
CTRI/2015/10/006328 [Registered on: 29/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of Clonidine and Dexmedetomidine for the duration of Post-operative Pain relief by Femoro-Sciatic Nerve Block in the patients of below knee Surgeries. |
|
Scientific Title of Study
|
A comparative study of clonidine and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound guided femoro-sciatic block for postoperative analgesia in below knee surgeries under subarachnoid block
(a randomized controlled trial)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
bhanu gupta |
| Designation |
post graduate student |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
junior resident,Deptt. of Anaesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
bhanu gupta |
| Designation |
post graduate student |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
junior resident,Deptt. of Anaesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Associate Professor |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Associate Professor,Deptt. of Anaesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418710783 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. RPGMC Kangra at Tanda, H.P |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Dr. RPGMC Kangra at Tanda, Distt Kangra, H.P. 176001 |
| Type of Sponsor |
Government 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 |
| Bhanu Gupta |
Dr. RPGMC Kangra at Tanda |
Department of Anaesthesia, Dr. RPGMC Kangra at Tanda.
Kangra
HIMACHAL PRADESH |
9418016807
bhanurpgmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt. Medical College Kangra at Tanda H.P IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A comparative study of clonidine and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound guided femoro-sciatic block for postoperative analgesia in below knee surgeries under subarachnoid block (a randomized controlled trial) |
A comparative study of clonidine and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound guided femoro-sciatic block for postoperative analgesia in below knee surgeries under subarachnoid block (a randomized controlled trial) |
| Intervention |
A comparative study of clonidine and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound guided femoro-sciatic block for postoperative analgesia in below knee surgeries under subarachnoid block (a randomized controlled trial) |
A comparative study of clonidine and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound guided femoro-sciatic block for postoperative analgesia in below knee surgeries under subarachnoid block (a randomized controlled trial) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria –
1. Males and females between the age group 20-60 years.
2. ASA class I-II.
3. BMI 18.5-39.9.
4. Undergoing surgeries of leg and foot.
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal for block.
2. History of cardiac, renal or hepatic disease, CNS disorders, neuropathy.
3. Chronic treatment with calcium channel blockers.
4. Patients having bleeding disorders.
5. Hypersensitivity to local anaesthetics.
6. Local infection at the site where needle for block is to be inserted.
7. Knee surgery.
8. Allergic to study drugs.
9. Patients with known bradyarrythmia and on beta blocker therapy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure in this study is the time to first analgesic request. |
The primary outcome measure in this study is the time to first analgesic request. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measures include the number of supplemental analgesic requirements, VAS pain, nausea, patient satisfaction |
The secondary outcome measures include the number of supplemental analgesic requirements, VAS pain, nausea, patient satisfaction |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/04/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
to study the effect of adding adjuvent (clonidine and dexmedetomidine) to levo-bupivacaine in prolonging the post operative analgesia in below knee surgeries by femoro-sciatic nerve block.
|