CTRI Number |
CTRI/2023/06/054435 [Registered on: 26/06/2023] Trial Registered Prospectively |
Last Modified On: |
03/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Dexamethasone or Dexmedetomidine : The better helper for post-operative pain relief in femoral nerve blocks |
Scientific Title of Study
|
Comparison of post operative analgesic efficacy of dexamethasone with
dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided femoral nerve
block in unilateral total knee arthroplasty under spinal anaesthesia: a prospective
randomized control study
|
Trial Acronym |
nill |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Amolpreet Kaur |
Designation |
DNB registrar |
Affiliation |
Fortis Hospital Mohali |
Address |
Fortis hospital , Mohali
Amritsar PUNJAB 160062 India |
Phone |
9592047004 |
Fax |
|
Email |
kauramolpreet@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Suman Shekhawat |
Designation |
consultant |
Affiliation |
Fortis Hospital Mohali |
Address |
anaesthesia department, Fortis hospital , Mohali
Rupnagar PUNJAB 160062 India |
Phone |
7888423534 |
Fax |
|
Email |
drsumanshekhawat@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Amolpreet Kaur |
Designation |
DNB registrar |
Affiliation |
Fortis Hospital Mohali |
Address |
anaesthesia department, Fortis hospital , Mohali
Amritsar PUNJAB 160062 India |
Phone |
9592047004 |
Fax |
|
Email |
kauramolpreet@gmail.com |
|
Source of Monetary or Material Support
|
Fortis hospital. Phase 8, Sector 62, Mohali 160062 |
|
Primary Sponsor
|
Name |
fortis hospital mohali |
Address |
Fortis hospital, Sector 62, Phase 8, Mohali, Punjab |
Type of Sponsor |
Private hospital/clinic |
|
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 Amolpreet Kaur |
Fortis Hospital Mohali |
Ortho icu 1, Anaesthesia department Rupnagar PUNJAB |
9592047004
kauramolpreet@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee, fortis hospital, Mohali |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Dexamethasone |
Monitoring the 24 hour post operative analgesia provided with 8mg Dexamethasone as an adjuvant to 30ml of 0.375% Ropivacaine in femoral nerve block given peri-operatively in patients undergoing unilateral total knee arthroplasty under spinal anesthesia. |
Intervention |
Dexmedetomidine |
Using Dexmedetomidine in dose of 1mg/kg, as an adjuvant to 30ml of 0.375% Ropivacaine in peri-operative femoral nerve block in patients undergoing unilateral total knee arthroplasty under spinal anesthesia and monitoring the analgesic efficacy in the first 24 hours post operatively. |
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA 1 and 2
consenting to participate
able to comprehend and coperate
posted for unilateral total knee arthroplasty |
|
ExclusionCriteria |
Details |
patient refusal
obese patient BMI >35
ASA 3,4
patients with history of OSA or substance abuse, or chronic opiod use.
allergy to local anaesthetic or any drugs used in trial
contra-indication to spinal anaesthesia or posted under general anaesthesia
patients with hearing or cognitive dysfunction
patients on anticoagulants/ history of bleeding disorders
pre-existing peripheral neuropathoies |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
average VAS score between the two groups within first 24 hours |
0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
time of first administration of rescue analgesic |
within 24 hours |
to measure the total number of opioid boluses required over the first 24 hours post operatively |
within 24 hours |
compare the number of patients requiring opioid bolus in the first 24 hours in each group |
within 24 hours |
to compare the number of patients amongst each group who report a VAS score of more than or equal to 4 within first 24 hours post operative |
0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
30/06/2023 |
Date of Study Completion (India) |
02/02/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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
|
This study is a double blind prospective randomized control trial to evaluate the analgesic efficacy of dexamethasone and dexmedetomidine, as an adjuvant to 0.375% ropivacaine in ultrasound guided femoral nerve block. This study will be done on 120 ASA I -II patients undergoing unilateral total knee arthroplasty at of Fortis hospital, Mohali. All eligible and consenting patients will be explained VAS score beforehand and given intrathecal 0.5% heavy bupivacaine (dose in range of 2.8-3.4 ml) along with femoral nerve block. Under no circumstances the dose of bupivacaine will exceed 2mg/kg body weight. Patients will be divided between two groups via computer generated randomisation. For femoral nerve block, Group A will receive 8mg dexamethasone with 30ml of 0.375% ropivacaine and group B will receive 1mcg /kg dexmedetomidine with 30ml of 0.375% ropivacaine. The investigator as well as the patient will be blinded about the drug being used. Post operative VAS score and need for rescue analgesia, will be assessed for 24 hours and compared between the two groups. Any adverse effects will also be reported. Based on existing studies using said adjuvants in femoral nerve block, both dexamethasone and dexmedetomidine have been shown to prolong the duration of block and reduce the requirement of opioids. There is a dearth of studies comparing both adjuvants in femoral nerve block, hence our study aims to fill that gap in knowledge. based on similar studies in other blocks, running hypothesis is that both adjuvants provide adequate analgesia but dexamethasone might prove to have a lower over-all VAS score and requirement for rescue analgesia. |