| CTRI Number |
CTRI/2017/08/009521 [Registered on: 28/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relief with clonidine, dexamethasone and dexmedetomidine as an adjuvant to local anesthetics in Femoral nerve block - which works better? |
|
Scientific Title of Study
|
Comparison of Clonidine vs Dexmedetomidine vs Dexamethasone as an adjuvant to local anesthetic for Femoral nerve block in patient for elective anterior cruciate ligament reconstruction surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumit Vaghani |
| Designation |
MBBS DNB Anaesthesia Diploma in Anaesthesia |
| Affiliation |
Ganga Medical Center and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of anesthesiology,
5th floor, Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
9558000952 |
| Fax |
|
| Email |
sumitvaghani277@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sumit Vaghani |
| Designation |
MBBS DNB Anaesthesia Diploma in Anaesthesia |
| Affiliation |
Ganga Medical Center and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of anesthesiology,
5th floor, Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
9558000952 |
| Fax |
|
| Email |
sumitvaghani277@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr J Balavenkatsubramanian |
| Designation |
Senior Consultant Anesthesiology |
| Affiliation |
Ganga Medical Center and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of anesthesiology,
5th floor, Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
|
| Fax |
|
| Email |
drbalavenkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre and Hospital |
| Address |
313 Mettupalayam Road
Opposite Saibaba koil
Coimbatore 641043
Tamilnadu
India |
| 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 |
| Sumit Vaghani |
Ganga Hospital, Coimbatore |
Department of orthopaedic and trauma, 5th floor operation theatre complex
Coimbatore TAMIL NADU |
9558000952
sumitvaghani277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient having anterior cruciate ligament injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 1 mcg/kg of clonidine under combined ultrasonography and peripheral nerve stimulation guidance |
| Comparator Agent |
Dexamethasone |
Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 8 mg of dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance |
| Comparator Agent |
Dexmedetomidine |
Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 1 mcg/kg of Dexmedetomidine under combined ultrasonography and peripheral nerve stimulation guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients of ASA physical status I and II
2) Patient posted for elective surgical procedure |
|
| ExclusionCriteria |
| Details |
1) Patient less than 18 year and more than 65 year
2) Pregnant and lactating women
3) Hemodynamically compromised patient
4) Non consenting patient/relatives refusal for procedure
5) Surgery on emergency patients with associated uncontrolled systemic disease
6) Patients in ASA physical status III and IV
7) Allergic to Medication
8) Bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score less than 3 (Duration of Analgesia) |
48 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset and Duration of Sensory blockade, Rescue Analgesia |
48 Hours |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
18/12/2013 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective
randomized double blind controlled trial including 90 ASA I & II patients
between age 18 – 65 yrs for elective arthroscopic anterior cruciate ligament
reconstruction surgery divided into 3 groups Group A Clonidine plus
Bupivacaine, Group B Dexmedetomidine plus Bupivacaine and Group C Dexamethasone
and Bupivacaine. The study compares the effects of clonidine,
dexmedetomidine and dexamethasone as an adjuvant to bupivacaine in arthroscopic
anterior cruciate ligament reconstruction surgeries in postoperative
period for 24 hrs after ultrasound and peripheral nerve stimulation guided
femoral nerve block and thus concluding which drug combination produces better
analgesia with minimal haemodynamic alterations.
Finding
summary: Addition of Dexamethasone to local anesthetic drugs in femoral
block significantly prolongs the onset and duration of analgesia, sensory and
motor block as compared to clonidine and dexmedetomidine in patients undergoing
ACL reconstruction surgeries. Dexamethasone as an additive provides: Better
pain relief, prolongation of post operative analgesia and, decrease consumption
of systemic analgesics in post operative period with manageable hemodynamic
alterations. It is a remarkably, safe and cost effective method of providing
postoperative analgesia. US-guided brachial plexus block technique has several
advantages including faster onset and greater block success. |