| CTRI Number |
CTRI/2023/09/057327 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the clinical efficacy & safety of equal doses of Hyperbaric ropivacaine vs Hyperbaric bupivacaine for sub arachnoid block in knee arthroscopic surgery. |
|
Scientific Title of Study
|
A comparative evaluation of 0.75% hyperbaric ropivacaine vs 0.5% hyperbaric bupivacaine for subarachnoid block in knee arthroscopic surgery. A randomised prospective double blind 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 Seerat Grover |
| Designation |
Registrar |
| Affiliation |
Fortis Hosptial Mohali |
| Address |
Fortis Hospital Mohali
Anesthesia department
Fortis Hospital Mohali
Anesthesia department
Chandigarh
CHANDIGARH
160071
India |
| Phone |
8800767402 |
| Fax |
|
| Email |
seeratgrover1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kataria |
| Designation |
Consultant |
| Affiliation |
Fortis Hosptial Mohali |
| Address |
Fortis Hospital Mohali
Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
Anesthesia department
Fortis Hospital Mohali
Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
Anesthesia department
Chandigarh
CHANDIGARH
160071
India |
| Phone |
9872217274 |
| Fax |
|
| Email |
drkat22in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Kataria |
| Designation |
Consultant |
| Affiliation |
Fortis Hosptial Mohali |
| Address |
Fortis Hospital Mohali
Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
Anesthesia department
Fortis Hospital Mohali
Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
Anesthesia department
Chandigarh
CHANDIGARH
160071
India |
| Phone |
9872217274 |
| Fax |
|
| Email |
drkat22in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anesthesia department
Fortis Hospital Mohali
Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
|
|
|
Primary Sponsor
|
| Name |
FORTIS HOSPITAL |
| Address |
Fortis hospital Mohali Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062 |
| 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 Dinesh Kataria |
Fortis hospital mohali |
Fortis Hospital Sector 62, Sahibzada Ajit Singh Nagar, Punjab 160062
Chandigarh
CHANDIGARH |
9872217274
drkat22in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Fortis Hospital Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S832||Tear of meniscus, current injury, (2) ICD-10 Condition: S832||Tear of meniscus, current injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine |
To evaluate the clinical efficacy and safety of 3ml of 0.5% Hyperbaric bupivacaine for sub arachnoid block in knee arthroscopic surgery for a duration of 16 to 18 months |
| Intervention |
HYPERBARIC ROPIVACAINE |
To evaluate the clinical efficacy and safety 3ml of 0.75 % Hyperbaric ropivacaine for sub arachnoid block in knee arthroscopic surgery for a duration of 16 to18 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate,
ASA grade 1 and 2,
Age- 16-65 years,
Either gender scheduled for elective knee arthroscopic surgery under spinal anaesthesia,
Pt with BMI less then 35,
Patients who have given valid informed written consent.
|
|
| ExclusionCriteria |
| Details |
Patients of American society of Anaesthesiologists 3 and 4,
Patient refusal ,
Infection at the site of administration,
Coagulopathy ,
Spinal deformity,
Allergic to local anesthetic drugs ,
Lack of informed written consent ,
Duration of surgery greater than 120 mins,
Patients having allergy to study drug,
Patients with psychiatric disorder or history of drug abuse.
Patient unable to comprehend,
Morbidly obese patients (BMI greater than 35kg per m2),
Pregnant patients.
|
|
|
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 |
To compare the clinical efficacy & safety of equal doses 3ml of 0.75 % Hyperbaric ropivacaine with 3ml of 0.5% Hyperbaric bupivacaine for sub arachnoid block in knee arthroscopic surgery for a duration of 16 to 18 months
|
1.The onset of Sensory block till T 10
2.The onset of Motor block.
3.Time for two segment regression of sensory block
4.The complete duration of sensory & motor block
5.Intraoperative Haemodynamics.
6.Intraoperative complications.
7.Time to first rescue analgesic.
8.Time to micturition.
for a duration of 16 to 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study & compare the side effect profile of the two drugs,
To study the intraoperative and post operative complications.
|
Intraoperative vitals at 1min, 5min,10min,15min,20min,25min,30min,45min,60min,75min,90min,120min
Post operative vitals at 0min,30min,1hr,1.5hr,2hr,2.5hr,3hr. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Our study is a randomised prospective double blind study that will be done to compare the efficacy and safety of the two study drugs namely hyperbaric 0.75% ropivacaine and hyperbaric 0.5% bupivacaine. The study will be done in patients undergoing elective knee arthroscopic surgery being conducted at Fortis Hospital Mohali in the department of anaesthesia and critical care. Sample size of eighty will be taken and block randomisation done with Computerized Randomization Technique. Both the drugs would be distributed among the participants. The effect of the study drugs will be assessed using parameters like the onset of sensory and motor blocks ,time for regression from T10 level, complete duration of block and side-effect profiles etc. At the end, result of both the drugs will be compared and statistically analysed .Any complications will also be recorded. |