| CTRI Number |
CTRI/2024/07/070587 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between 0.25 percent of Bupivacaine and 0.25 percent of Ropivacaine with Dexamethasone in ultrasound guided femoral nerve block for post operative analgesia after total knee arthroplasty |
|
Scientific Title of Study
|
Comparison between 0.25 percent of Bupivacaine and 0.25 percent of Ropivacaine with Dexamethasone in ultrasound guided femoral nerve block for post operative analgesia after total knee arthroplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Angela Abraham |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesia KMC Mangalore
Dakshina Kanada
Karnataka
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9868287935 |
| Fax |
|
| Email |
angela.kmcmlr2022@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ranjan Rao |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesia KMC Mangalore
Dakshina Kanada
Karnataka
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9449837154 |
| Fax |
|
| Email |
drranjanrao@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Angela Abraham |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesia KMC Mangalore
Dakshina Kanada
Karnataka
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9868287935 |
| Fax |
|
| Email |
angela.kmcmlr2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical CollegeLight House Hill Road,
Mangalore
575001 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Light House Hill Road,
Mangalore
575001 |
| 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 Rajan Rao |
Kasturba Medical College, Mangalore |
Department of Anaesthesiology Kasturba Medical College, Light House Hill road,
Mangalore-575001 Dakshina Kannada KARNATAKA |
9449837154
drranjanrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The patients undergoing total knee arthroplasty under regional anesthesia.
The patient falling in American society of anaesthesiology grade I ,II and III.
Age 30-80 yrs
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patient with a history of allergy to the drugs used in the study.Patients with infection at the site of subarachnoid block or femoral nerve block.
Patients with pre-existing peripheral neuropathy.
Patients with impaired renal and liver function, coagulopathy.
Patients with documented history of opioid sensitivity and/or allergy to NSAIDs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of action of block
2.First time rescue analgesics consumed
3.Total amount of rescue analgesia consumed
4.Time taken for ambulation post surgery
|
To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess duration taken for ambulation of patient postoperatively.
|
After 12hours, 24hours |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="0" 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
|
Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction. The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic dis- ease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteers . Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction. The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic disease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteers. Dexamethasone added to local anaesthetics (LAs) appears to prolong single-injection nerve block. The analgesic effects of spinal and systemic corticosteroids combined with LAs have proven to be effective in humans, whereas dexamethasone microspheres have increased block duration . The purpose of the study is to compare difference in post operative analgesic duration, amount of sedation and systemic side effects in 0.25%bupivacaine and 4mg dexamethasone with 0.25% ropivacaine and adjuvant 4mg dexamethasone using femoral nerve block as a post operative analgesia in TKR |