| CTRI Number |
CTRI/2024/12/078183 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post operative adductor canal block for lower limb surgery
|
|
Scientific Title of Study
|
TO STUDY THE ANALGESIC EFFICACY OF USG GUIDED ADDUCTOR CANAL BLOCK AFTER KNEE ARTHROPLASTY AND ARTHROSCOPIC SURGERIES:A PROSPECTIVE OBSERVATIONAL STUDY. |
| 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 Binita Prajapati |
| Designation |
2nd year resident doctor in Anaesthesia |
| Affiliation |
Government medical college,surat |
| Address |
Second floor,old college building, Anaesthesia department, government medical college,majura gate surat.
Surat
GUJARAT
395001
India |
| Phone |
6355408196 |
| Fax |
|
| Email |
binitaprajapati525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignasha Patel |
| Designation |
Assistant Professor |
| Affiliation |
New government medical college surat |
| Address |
Anaesthesia department, government medical college Surat
Surat
GUJARAT
395001
India |
| Phone |
9924177720 |
| Fax |
|
| Email |
jignasha72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jignasha Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college,surat |
| Address |
Second floor, anesthesia department, government medical college surat,near majura gate surat,Gujarat, India,pin code 395001
Surat
GUJARAT
395001
India |
| Phone |
9924177720 |
| Fax |
|
| Email |
jignasha72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Second floor,old college building, Anaesthesia department, government medical College surat near majura gate,pin code 395001,Gujarat,india |
|
|
Primary Sponsor
|
| Name |
Government Medical College Surat |
| Address |
Second floor, old college building, Anaesthesia department, government medical College surat, near majura gate surat,pin code-395001, Gujarat, India |
| Type of Sponsor |
Government 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 Binita Prajapati |
Government medical college surat |
Second floor, old college building, Anaesthesia department,majura gate surat pin code 395001,Gujarat,India
Surat
GUJARAT |
6355408196
binitaprajapati525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee of GMC Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided adductor canal block after knee arthroplasty and arthroscopic surgeries. |
All aseptic precautions will be taken and the USG machine is placed on opposite side of limb that had to be blocked.The patient is positioned supine with the knee slightly bent and the leg externally rotated.A high frequency linear transducer is positioned in a transversely oriented over the medial thigh halfway between the ASIS and the superior patellar pole.The femoral artery and veins are visualised deep to the sartorius muscle,and the saphenous nerve lies anterior to the vessels.The block needle is placed 2 to 3cm lateral to the transducer directed lateral to medial and advanced in-plane to the triangular space deep to the sartorius muscle and anterior to the artery.After careful aspiration for non appearance of blood,local anaesthetic will be injected.At L1 level regression of spinal anaesthesia adductor canal block is given and post operative monitoring of visual analogue score(VAS) upto 24hours. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)patient posted for knee arthroplasty and arthroscopic surgeries under spinal anesthesia
2)patient age group 18 to 70years
3)patient belonging to ASA class 1 to 3
|
|
| ExclusionCriteria |
| Details |
1)patient refusal
2)infection at the site of needle insertion
3) allergy to any drug used in block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality and duration of post operative analgesia |
30 Minutes of block see VAS score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)pain on knee joint movement
2)Requirement of Rescue analgesia in 24 hours |
will record VAS score
1)at 8pm
2)at 8am next day of morning
3)at 24 hours of blocks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 arthroplasty involve extensive bone resection and soft tissue manipulation ,and in case of arthroscopic surgeries continuous high pressure fluid irrigation is there,so these patient suffer severe pain during early post operative period.Proper pain control is necessary in such case for early ambulaton and physiotherapy, It results in faster recovery , decrease the risk of post operative pain and comlication, and imrove patient satisfaction.
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