| CTRI Number |
CTRI/2025/03/082779 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two pain relief blocks for knee ligament surgery |
|
Scientific Title of Study
|
Comparative evaluation of addition of genicular nerve block versus ipack block on post-operative analgesic efficacy of adductor canal block in patients undergoing anterior cruciate ligament repair under spinal anaesthesia. |
| 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.Vansh Priya |
| Designation |
Additional professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology
Apex Trauma Centre SGPGIMS
Lucknow Uttar Pradesh 226014
India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8005385095 |
| Fax |
|
| Email |
vanshkhr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vansh Priya |
| Designation |
Additional professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology
Apex Trauma Centre SGPGIMS
Lucknow Uttar Pradesh 226014 India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8005385095 |
| Fax |
|
| Email |
vanshkhr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ashi Chaudhary |
| Designation |
Junior Resident Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology
Apex Trauma Centre SGPGIMS Lucknow Uttar Pradesh 226014
India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004902845 |
| Fax |
|
| Email |
itsashichaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Sanjay Gandhi Post-Graduate Institute of Medical Sciences Raebareli Road Lucknow Uttar Pradesh 226014 India |
| 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 Vansh Priya |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Anaesthesiology
Apex Trauma Centre
Sanjay Gandhi Post-Graduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India
Lucknow
UTTAR PRADESH |
08005385095
vanshkhr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of Genicular Nerve Block Versus Ipack Block to Adductor Canal Block |
To compare the post-operative analgesic efficacy of blocks in patient undergoing anterior cruciate ligament surgery under spinal anaesthesia. |
| Comparator Agent |
Adductor Canal Block + Genicular Nerve Block |
Adductor Canal Block(20 ML 0.375% Ropivacaine) + Genicular Nerve Block(15 ML 0.375% Ropivacaine)
Drug will be delivered in 30 seconds single shot perineural |
| Comparator Agent |
Adductor Canal Block + Ipack Block |
Adductor Canal Block( 20 ML 0.375% Ropivacaine) + Ipack(20 ML 0.375% Ropivacaine)
Drug will be delivered in 30 seconds single shot perineural |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have given written informed consent
Patient belonging to ASA grade 1 and 2
Patient in age group between 18-50 and weighing above 50 KG.
Patient in whom hamstring graft is used for repair. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patient belonging to ASA Grade 3 and 4.
Patient with allergy and intolerance to local anaesthetics and have active skin infection at injection site.
Patient with cognitive impairment delirium and delirium.
Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anaesthesia.
Pre-existing peripheral neuropathy, chronic pain ,opioid use.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean opioid consumption |
At the end of 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Median Static & Dynamic NRS(Numerical Rating Score).
Early function related outcomes were assessed using IKDC subjective knee evaluation form . |
NRS AT 2,4,6,12,18 AND 24 Hours
IKDC Form at Pre-operative visit & 1 month post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="6"
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
|
Anterior cruciate ligament (ACL) is the most commonly damaged ligament in the knee largely affecting young adults. ACL reconstruction is now being largely performed as an out-patient surgery and early rehabilitation is one of the primary goals of this surgery. The achievement of aforementioned goals is largely dependent on an effective analgesic regimen that minimizes the role of systemic analgesics yet provides adequate postoperative pain control, eliminates the need for overnight stay and facilitates early rehabilitation. Antero-medial side of knee is innervated by saphenous nerve, nerve to vastus medialis, medial branch of nerve to vastus intermedius. Antero-lateral side of knee is innervated by nerve to vastus lateralis and lateral branch of vastus intermedius. Posterior division of obturator nerve and terminal branches of sciatic nerve supply the posterior aspect of knee joint. Ultrasound guided (USG) Adductor canal block (ACB) by targeting saphenous nerve and nerve to vastus medialis is ideally suited to provide analgesia without causing quadriceps weakness and has been demonstrated to reduce pain and opioid consumption after major knee surgery. Genicular nerve block (GNB) targets the three genicular nerves (supero-medial, supero-lateral, infero-medial) supplying the anterior knee joint. Recently, USG guided iPACK (infiltration of local anaesthetic between the popliteal artery and the posterior capsule of the knee) by targeting genicular nerves and popliteal plexus has shown to provide motor-sparing posterior knee analgesia. Based on knee innervation, we hypothesise that ACB supplemented with GNB would provide better post-operative analgesia than ACB supplemented with iPACK, in patients undergoing ACL repair under spinal anaesthesia. After obtaining approval from the institutional ethics committee of SGPGIMS and written informed consent from the patients, the study will be conducted over a period of 18 months in patients undergoing ACL repair surgery. A thorough pre-anaesthetic evaluation will be done a night before surgery and procedure (spinal anaesthesia followed by regional anaesthesia) will be explained to the patient. Patients satisfying eligibility criterion will be randomly categorized as under 2 groups as- group A, B . All standard ASA monitors will be attached. Spinal anaesthesia will be administered in sitting position under complete aseptic precautions using 25G Quincke’s spinal needle in L3-L4 interspace using 15mg of Injection heavy bupivacaine (0.5%) with 15mcg of Inj fentanyl as adjuvant. After assessing adequacy of the effect of spinal anaesthesia, patient will be administered USG guided regional anaesthesia according to the group allocation. GROUP A will be given USG guided ACB with 20ml of 0.375% ropivacaine + iPACK block with 20ml 0.375% ropivacaine . GROUP B will be given ( adductor canal block with 20 ml 0.375% ropivacaine + genicular nerve block with 15 ml 0.375% ropivacaine. Injection Dexamethasone (0.1 mg/kg i.v) will be administered as adjuvant to prolong the duration of block. Injection Paracetamol (1gm i.v) will be administered 6 hourly as part of multi-modal analgesia. Gracilis and Semitendinosis hamstring tendon will be used for single bundle ACLR. Primary Objective of the study is mean opioid consumption at the end of 24 hrs. Post operatively, static and dynamic pain assessment will be done at 2hr,4hr,6hr,12hr,18hr,24hr using NRS. Dynamic pain will be assessed by asking the patient to elevate operated limb by 15 degrees. NRS score > 4 will be treated as breakthrough pain and will be treated by administering injection Fentanyl (1mcg/kg,iv). Subsequent to that patient will be observed for 30 minutes and in absence of any pain relief, injection Diclofenac (75 mg iv) will be administered. Patients with NRS score > 4 within first 6 hours of post-operative observation, will be treated as block failure and will be analysed according to “intention to treat” principle. Patient will be requested to complete IKDC form (International knee documentation committee) preoperatively and at 1 month post-operatively. |