| CTRI Number |
CTRI/2025/09/094504 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of ultrasound guided analgesic block injection vs local infiltration analgesia for postoperative pain relief after total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of ultrasound guided dual subsartorial block and local infiltration analgesia for postoperative analgesia after total knee arthroplasty - A randomized comparative 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 SHYAM SUNDER |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Dept of orthopaedics
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES
Ganapathichettikulam
Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8056194019 |
| Fax |
|
| Email |
shyam.arun90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHYAM SUNDER |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Dept of orthopaedics
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES
Ganapathichettikulam
Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8056194019 |
| Fax |
|
| Email |
shyam.arun90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHYAM SUNDER |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Dept of orthopaedics
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES
Ganapathichettikulam
Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8056194019 |
| Fax |
|
| Email |
shyam.arun90@gmail.com |
|
|
Source of Monetary or Material Support
|
| PONDICHERRY INSTITUTE OF MEDICAL SCIENCES - INTRAMURAL GRANT
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES ,KALATHUMETTUPETTAI, GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY , INDIA , PINCODE -605014 |
|
|
Primary Sponsor
|
| Name |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES ,KALATHUMETTUPETTAI, GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY , INDIA , PINCODE -605014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shyam sunder |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ORTHOPAEDICS AND ANAESTHESIOLOGY, ORTHO OT NUMBERS 10 AND 11,ARTHROPLASTY DIVISION, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES ,KALATHUMETTUPETTAI, GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY , INDIA , PINCODE -605014
Pondicherry
PONDICHERRY |
8056194019
shyam.arun90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
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 |
GROUP A - DUAL SUBSARTORIAL BLOCK |
Group A will receive an ultrasound-guided Dual Subsartorial Block (DSB) performed by an experienced anesthesiologist (with over 5 years of experience in ultrasound-guided regional anesthesia techniques) immediately after surgery and dressing application. The block will be administered using a prepared local anesthetic solution consisting 50ml of 0.2% ropivacaine and (2ml )8 mg of adjunct medication , 25ml in the distal femoral triangle and 25ml in proximal adductor canal.
|
| Comparator Agent |
Group B- Local periarticular infiltration analgesia |
Group B will receive Periarticular infiltration (PAI) with 50ml of 0.2% ropivacaine (100mg) + Cefuroxime 750 mg – 10 cc reconstituted in normal saline + 2 ml (8 mg) dexamethasone (total volume 62ml) administered intra operatively by the same surgeon. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.)Patients belonging American Society of Anesthesiologists (ASA) physical status of I-III.
2.)Patients aged 30–85 of either sex. |
|
| ExclusionCriteria |
| Details |
1.)Body mass index (BMI) greater than 35 kg/m2
2.)Severe valgus deformity
3.)Acute/chronic kidney disease
4.)Operative limb neuropathy
5.)Known allergies to local anesthetic agent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the effect of ultrasound guided dual subsartorial block on postoperative analgesia during the first 24hrs in comparison to periarticular infiltration among patients undergoing total knee arthroplasty under spinal anesthesia |
VAS, to measure pain intensity in both the groups in first 24 hrs.
Time for first rescue analgesia and total dose of rescue analgesia
Quadriceps strength
Quality of recovery using QOR – 15 scale
Adverse effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time duration for requirement of first rescue analgesia.
To compare the total number of breakthrough analgesics administered during the initial 24-hour postoperative period.
To compare the quadriceps strength by measuring the total ambulation distance & the degree of active knee extension within the first 24 hours postoperatively.
To determine the quality of recovery using QOR – 15 scale after 24 hrs of surgery in both the groups.
To record any adverse effects, such as nausea, vomiting, buckling, deep vein thrombosis, wound infection. |
AFTER 24 HOURS OF SURGERY |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1"
Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shyam.arun90@gmail.com].
- For how long will this data be available start date provided 01-03-2027 and end date provided 31-03-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
our study if focused on comparing the efficacy of dual subsartorial block as a targeted regional anesthesia technique for total knee replacement arthrioplasty .A direct comparison of the modality with periarticular infiltration remains unexplored in the current literature. therefore our study findlings will have significant implications for orthopaedic surgeons and anaesthesiologist enabling them to choose the most effective analgesic regimen for optimal perioperative pain management |