| CTRI Number |
CTRI/2024/07/070941 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Continuous Adductor canal block and continuous femoral nerve block for post operative analgesia in knee arthroscopic surgeries |
|
Scientific Title of Study
|
Evaluation of Analgesic Effect of Continuous Adductor Canal Block versus Continuous Femoral Nerve Block for Knee Arthroscopic Surgeries : A Randomised Clinical Trial |
| 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 Harshita Kotian |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, 3rd floor, Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9769452864 |
| Fax |
|
| Email |
harshitak9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Basavaraj Patil |
| Designation |
Associate Professor |
| Affiliation |
Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, 3rd floor, Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
7829655342 |
| Fax |
|
| Email |
drbnp2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshita Kotian |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, 3rd floor, Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9769452864 |
| Fax |
|
| Email |
harshitak9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, India -586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, India - 586103 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Basavaraj Patil |
Shri B M Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshita Kotian |
Shri B M Patil Medical College, Hospital and Research Centre |
Department of Anaesthesiology, Vijayapura, Karnataka, India -586103
Bijapur
KARNATAKA |
9769452864
harshitak9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE (Deemed to be University) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous Adductor Canal Block |
Post operatively continuous Adductor Canal block will be given with Ropivacaine 0.2% at the rate of 5 ml/hr for 24 hours and assessed for pain over 24 hours and time for rescue analgesia |
| Comparator Agent |
Continuous Femoral Nerve Block |
Post operatively continuous Femoral Nerve block will be given with Ropivacaine 0.2% at the rate of 5 ml/hr for 24 hours and assessed for pain over 24 hours and time for rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective knee arthroscopic surgeries
patients classifies as ASA Grade I and II
|
|
| ExclusionCriteria |
| Details |
Infection at block site
Patients having Coagulopathy
Polytrauma patients
Patients on Chronic analgesic therapy
Body mass index of more than 35 kg/m2
Patients with fixed knee deformities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for first rescue analgesia after starting continuous nerve block infusion in the both the groups |
Assess pain and note the time duration of rescue analgesia and any adverse event in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total analgesia required in first 24 hours postoperatively |
Note analgesia requirement for 24 hours and any adverse event |
| To compare the pain severity via VAS score during first 24 hours postoperatively |
Assess VAS score, hemodynamic variables and any adverse event every hour for 24 hours |
| To evaluate Quadriceps muscle strength |
To assess painless range of motion of knee after one week when and any adverse event throughout one week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/07/2024 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - on need basis
- For how long will this data be available start date provided 11-07-2024 and end date provided 11-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Aim: To evaluate the analgesic effect of continuous adductor canal block versus continuous femoral nerve block for knee arthroscopic surgeries.
Need for the Study: Postoperative pain management is a major drawback of knee arthroscopic surgeries. There is increased demand for pain management with fewer adverse effects, early mobilization, and shorter hospital stays. Peripheral nerve block satisfies these criteria and is becoming the treatment of choice.
Hypothesis: Continous Adductor canal block is superior to continuous femoral nerve block in providing postoperative analgesia in knee arthroscopic surgeries. |