CTRI Number |
CTRI/2020/03/024180 [Registered on: 23/03/2020] Trial Registered Prospectively |
Last Modified On: |
29/05/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To study effect of adductor canal infiltration given by operating surgeon on pain management and recovery in patients undergoing total knee replacement. |
Scientific Title of Study
|
Effect of surgeon administered adductor canal infiltration through operative exposure as an adjuvant to periarticular infiltration in pain management and early functional recovery after total knee arthroplasty (TKA) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajesh Maniar |
Designation |
Head Of Department, Department of Orthopaedics |
Affiliation |
Lilavati hospital and Research Centre, |
Address |
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
Mumbai (Suburban) MAHARASHTRA 400050 India |
Phone |
|
Fax |
|
Email |
drmaniar@jointspeciality.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh Maniar |
Designation |
Head Of Department, Department of Orthopaedics |
Affiliation |
Lilavati hospital and Research Centre, |
Address |
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
Mumbai (Suburban) MAHARASHTRA 400050 India |
Phone |
|
Fax |
|
Email |
drmaniar@jointspeciality.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rajesh Maniar |
Designation |
Head Of Department, Department of Orthopaedics |
Affiliation |
Lilavati hospital and Research Centre, |
Address |
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
Mumbai (Suburban) MAHARASHTRA 400050 India |
Phone |
|
Fax |
|
Email |
drmaniar@jointspeciality.com |
|
Source of Monetary or Material Support
|
Lilavati hospital and Research Centre,
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
|
|
Primary Sponsor
|
Name |
Dr Rajesh Maniar |
Address |
Lilavati hospital and Research Centre,
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
|
Type of Sponsor |
Other [Self] |
|
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 Rajesh Maniar |
Lilavati hospital and Research Centre, |
A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
Mumbai (Suburban) MAHARASHTRA |
9821422246
drmaniar@jointspeciality.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical & Health Research (EC-BHR) |
Approved |
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical and Health Research (EC-BHR) |
Approved |
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical and Health Research (EC-BHR) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Surgeon administered adductor canal infiltration and periarticular infiltration from primary exposure of joint. |
Current practice is to give periarticular infiltration from the primary exposure for pain relief. This will form our control group. In the study group we will give an additional surgeon administered adductor canal infiltration from the primary exposure of joint. |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
i) Unilateral total knee replacement
ii) Primary total knee replacement
iii) Spinal anesthesia only
iv) Willing to participate in study and sign consent form
|
|
ExclusionCriteria |
Details |
i) Bilateral Total Knee Replacement
ii) Revision Total Knee Replacement
iii) Medical conditions (eg : chronic kidney disease) requiring alteration in pain management protocol
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Pain by Visual Analogue scale
2) Analgesic consumption (PCA consumption) |
1) Preoperatively,
6 hours Postoperatively
Postoperative Day 1,
Postoperative Day 2,
Postoperative Day 3
2) 6 Hours postoperatively
Postoperative Day 1,
Postoperative Day 2,
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Flexion
2) TUG test
3) Time to meet discharge in hours |
1) Preoperatively,
Post operative Day 1,
Post operative Day 2,
Postoperative Day 3,
Post operative Day 14
2) Preoperatively,
Post operative Day 1,
Post operative Day 2,
Postoperative Day 3,
Post operative Day 14
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
23/03/2020 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Pepper AM, North TW, Sunderland AM, Davis JJ. Intraoperative Adductor Canal Block for Augmentation of Periarticular Injection in Total Knee Arthroplasty: A Cadaveric Study. J Arthroplasty. 2016 Sep;31(9):2072-6.14.
2) Koh IJ, Choi YJ, Kim MS, Koh HJ, Kang MS, In Y. Femoral Nerve Block versus
Adductor Canal Block for Analgesia after Total Knee Arthroplasty. Knee Surg Relat Res. 2017 Jun 1;29(2):87-95.
3) 17. Max Greenky et al, Intraoperative Surgeon Administered Adductor Canal Blockade is not Inferior to Anesthesiologist Administered Adductor Canal Blockade:A Prospective Randomized Trial. J Arthroplasty. 2020 Feb; https://doi.org/10.1016/j.arth.2020.02.011
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Pain management post Total Knee Arthroplasty (TKA) has improved significantly over the last decade with the current practice involving a multimodal strategy. One of the most important issues concerning patients is immediate postoperative pain. Post TKA , upto 60 % patients have severe knee pain and 30% have moderate knee pain. Effective pain management using a multimodal approach promises to decrease complications, improve outcomes, and increase patient satisfaction after hip and knee arthroplasty. Current strategies involve using peripheral nerve blockade, periarticular injections, and multimodal oral opioid and nonopioid medications during the perioperative and postoperative periods to provide superior pain control. Local periarticular infiltration of analgesic agents has been found to effectively control pain and improve functional outcome. A cocktail of drugs like bupivacaine, ketorolac, epinephrine and saline are being used. Peripheral nerve blocks help improves pain control and reduces opioid requirements. Femoral nerve bocks significantly improve analgesia control and shortens the time of functional recovery as compared to epidural analgesia or intravenous opioids. Femoral nerve blocks are associated with reduction in quadriceps strength and increased chances of fall. This in turn delays functional recovery and lengthens hospital stay. Adductor canal block (ACB) is a relatively newer technique for pain management. It helps improve quadriceps function as opposed to femoral nerve blocks which reduces quadriceps function. At the same time, the analgesic effect of adductor canal block is comparable to that of femoral nerve block. Anatomical study of adductor canal showed that the adductor canal contained multiple afferent sensory nerves (e.g. saphenous nerve, medial femoral cutaneous, and medial retinacular nerve etc.) but only a single efferent motor nerve (vastus medialis of the quadriceps muscle) that potentially affected motor function. Therefore, ACB may have a minimal effect on quadriceps muscle strength, but provides a comparable level of pain relief and early mobilization. Pepper et al [1] in their cadaveric study used a 1.5 inch 18 gauge blunt fill needle directed posteriorly at the level of the adductor tubercle in the supracondylar region, angled approximately 15° medial in relation to the sagittal plane, with the needle buried until the syringe hub met resistance to access the adductor canal. They found that this method had an 86% accuracy in accessing the adductor canal with no episode of damage to the femoral artery. They state that intraoperative ACB augmentation of peri articular infiltration is anatomically feasible and safe. Various studies show that adductor canal block is an effective tool in controlling pain post TKA. [2] Routine practice involves ultrasonography guided adductor canal block given pre operatively. It involves injecting in the distal adductor canal with a success rate as high as 95.6%. Pepper et al found that it was possible to reach the distal adductor canal from the joint, thereby eliminating the need of an extra procedure in giving adductor canal block. Max Greenky et al found that surgeon administered adductor canal block is not inferior to anesthetist administered adductor canal block[3]. To the best of our knowledge there is no study assessing the additive effects of adductor canal infiltration given intraoperatively from the joint. (Search engines used : PubMed, OVID, Elsevier, JBJS, Google Scholar). We believe this to be an easy and efficient method of adductor canal infiltration thereby decreasing the cost to the patient and removing the need of an extra invasive procedure after the surgery. 1)ResearchQuestion:Does intraoperative adductor canal infiltration from primary exposure of joint have an additive effect on postoperative pain management and early functional recovery in patients undergoing TKA ? Aims : To assess additive effect of intraoperative adductor canal infiltration in management of postoperative pain in patients undergoing TKA and early postoperative function post TKA |