| CTRI Number |
CTRI/2025/09/095459 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
POSTOPERATIVE PAIN MANAGEMENT
STRATEGIES AND THEIR IMPACT ON RECOVERY AFTER TOTAL KNEE ARTHROPLASTY . |
|
Scientific Title of Study
|
Postoperative pain management strategies and their impact on Recovery after Total Knee Arthroplasty . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhiyank Kumar |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Orthopaedic Surgery , Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9654545226 |
| Fax |
07152 287714 |
| Email |
drabhiyankkumar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bhushan Patil |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Orthopaedic Surgery , Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9011721049 |
| Fax |
07152 287714 |
| Email |
Bhushann1001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bhushan Patil |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Orthopaedic Surgery , Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9011721049 |
| Fax |
07152 287714 |
| Email |
Bhushann1001@gmail.com |
|
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Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha , 442001 |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
SAWANGI MEGHE , WARDHA , MAHARASHTRA , INDIA , 442001 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhiyank Kumar |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
Department of Orthopaedic Surgery , Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha 442001 Wardha MAHARASHTRA |
9654545226 07152287714 drabhiyankkumar@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M172||Bilateral post-traumatic osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: M173||Unilateral post-traumatic osteoarthritis of knee, (4) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ANALGESICS (Nerve Blocks like Femoral Nerve Block ,Epidural Analgesia,Local Infiltration Analgesia , IPACK Block). |
The femoral nerve block (FNB) is a commonly employed method for managing postoperative pain following TKA. This technique involves the injection of a local anaesthetic near the femoral nerve to block its sensory branches, providing effective pain
relief. However, one of the notable drawbacks of FNB is its potential to induce motor blockade, which can lead to weakness in the quadriceps muscle, delayed ambulation, and a heightened risk of falls. Epidural analgesia, once a common approach for pain control in TKA,involves administering a continuous infusion of anaesthetic and opioid directly into the epidural space. Epidural analgesia provides potent and long-lasting pain relief, however, its use has declined with the rise of peripheral nerve blocks and LIA due to associated risks, such as urinary retention, hypotension,and delayed mobilization. In patients with contraindications to other methods,epidural analgesia remains an option. Local infiltration analgesia (LIA) is a widely employed technique for pain management in orthopedic procedures,particularly in joint replacement surgeries.Its popularity stems from its simplicity, cost-effectiveness, and reliable pain-relieving properties with minimal side effects. LIA involves administering a mixture of local anesthetics and adjuvants—such as opioids, neuromodulators, corticosteroids, and NSAIDs—via multiple injections directly into the surgical site. This cocktail helps target the painful areas around the joint, particularly those with high concentrations of free nerve endings. IPACK block (interspace between the popliteal artery and the posterior capsule of Knee procedure involves the injection of a local anaesthetic behind the knee,specifically targeting the terminal branches of the sciatic nerve. One of the primary advantages of the IPACK block is its ability to provide effective analgesia to the posterior knee without affecting the saphenous or common peroneal nerves, which are often involved in other nerve blocks. |
| Intervention |
MULTI MODAL ANALGESIA (NSAIDs, Acetaminophen, Gabapentinoids, NMDA Antagonits such as Ketamine , Dextromethorphan , immediate-release Opioids,Cognitive therapy, Peri-articular injections, and physical modalities such as Cryotherapy , TENS Therapy) |
Multimodal Analgesia (MMA), also called “balanced analgesia,” uses multiple analgesic medications, physical modalities, and cognitive strategies to affect peripheral and central nerve loci for pain treatment. In light of the adverse side effects of opioid medication .
The use of NSAIDs, acetaminophen, gabapentinoids, immediate-release opioids,cognitive therapy, peri-articular injections, and physical modalities, such as cryotherapy TENS Therapy will be reviewed in this topic to assist the modern orthopaedic surgeon in controlling pain in their patients in the postoperative period . It provides insight into special consideration for
certain patients who are opioid-tolerant or suffer from comorbid conditions.
Multimodal analgesia is the future for the alleviation of pain in many fields of medicine. The field of orthopaedic surgery has been at the forefront of this new tools clinical use and innovation for postoperative pain relief. This model shows benefits in many ways in the
clinical setting. Orthopaedic surgery can often be associated with significant pain in the early postoperative period. Balancing the need for pain control while In light of the adverse side effects of opioid medication, the MMA model of pain management allows physicians an array of medicine and other mitigating the risk of adverse modalities to help decrease the morbidity associated with opioid analgesics often used as
mono therapy . MMA provides a broad array of medications and strategies that
can be combined to work synergistically with one another to help orthopaedic surgeons treat their patients as productively and safely as possible. Recent studies corroborate the idea that this model helps decrease post-operative pain beyond the standard mono therapy opioid regimen. This leads to less opioid use and therefore less risk to the patient. Individual surgeons often create their regimens for how they approach MMA . |
| Comparator Agent |
OPIOIDS |
Opioids are a common medication used for severe acute pain. Orthopaedic surgeons commonly use them in the post-operative period for pain control like TRAMADOL .
There are significant risks associated with their use, including misuse, addiction, and overdose. Opioids bind the mu-opioid receptor and inhibit neurotransmitter release in the central nervous system.opioids be used in the smallest dose and for the shortest amount of time possible. Short-actingopioids are preferred and recommended, as compared to long-acting opioids, which provide less opioid absorption per unit of time. The oral administration of opioids is preferred to IV administration in postoperative patients who can tolerate the oral route. This results in a medication surplus that is then available for
misuse. Opioids tends to be taken as a misuse drug and may also involve diversion to use by persons in addiction not under the physician’s care.Adverse effects of opioids include nausea,vomiting,dizziness,constipation,somnolence, headache. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients 18-80 years undergoing elective total knee arthroplasty.
2.Ability to provide informed consent.
3.No pre-existing chronic pain disorders or opioid dependency.
4.Osteoarthritis/ Senile Osteoarthritis / Early Onset Osteoarthritis/ Traumatic Osteoarthritis |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate
2.Revision surgeries.
3.Patients with cognitive impairment or severe comorbidities
4.Tuberculosis Arthritis
5.Post TB Arthritis |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Multimodal pain management provides superior postoperative recovery outcomes compared to opioid-only and regional anesthesia strategies.Patients receiving multimodal therapy report lower pain scores and faster functional recovery than those managed with opioids alone. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The optimal strategy for multimodal analgesia in TKA ideally begins before surgery and continues throughout the perioperative period, extending into the post-discharge phase. A combination of oral and intravenous medications—including NSAIDs, selective COX-2 inhibitors, corticosteroids, gabapentinoids , acetaminophen, and opioids—can be utilised both before and after surgery to control pain effectively. In addition to pharmacological interventions, techniques like peripheral nerve blocks and periarticular local infiltration analgesia are valuable in managing postoperative pain and should be coordinated with the anesthesia team. Nonpharmacological methods, such as cryotherapy and physical therapy, should also be considered as part of the overall pain management plan. |
24 hrs |
|
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Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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 2 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="2" 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
|
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Brief Summary
|
As the global population continues to age, the incidence of TKA is expected to increase significantly. Effective pain management is a crucial aspect of TKA , playing a key role in enhancing recovery, improving patient satisfaction, and optimising overall healthcare outcomes. Multimodal analgesia has emerged as the standard approach for perioperative pain control in TKA , providing more effective pain relief with fewer adverse effects compared to opioid-based therapies. This method not only supports quicker recovery but also helps minimize opioid consumption.
The optimal strategy for multimodal analgesia ideally begins before surgery and continues throughout the perioperative period, extending into the post-discharge phase. A combination of oral and intravenous medications—including NSAIDs, selective COX-2 inhibitors, corticosteroids, gabapentinoids , acetaminophen, and opioids—can be utilised both before and after surgery to control pain effectively. In addition to pharmacological interventions, techniques like peripheral nerve blocks and periarticular local infiltration analgesia are valuable in managing postoperative pain and should be coordinated with the anesthesia team. Nonpharmacological methods, such as cryotherapy and physical therapy, should also be considered as part of the overall pain management plan. Multimodal Analgesics involves the use of multiple agents or modalities with different mechanisms of action targeting various pain pathways.
1.Pharmacological Interventions • Acetaminophen: A commonly utilized analgesic for managing perioperative pain, favored for its affordability, reliable effectiveness, minimal side effects, and general safety profile. Intravenous (IV) acetaminophen has been shown to reduce postoperative pain scores and opioid consumption after TKA. • NSAIDs and Selective COX-2 Inhibitors: These medications decrease prostaglandin production, which is responsible for sensitizing afferent nerve fibers and contributing to pain. Selective COX-2 inhibitors, such as celecoxib, target inflammation more specifically, reducing adverse effects associated with traditional NSAIDs. • Gabapentinoids : Medications like pregabalin and gabapentin are believed to reduce postoperative central sensitization and inflammation. However, their efficacy in TKA is mixed, with some studies showing reduced opioid use and others indicating no significant benefit. • NMDA Receptor Antagonists: Agents like ketamine have gained attention for their role in modulating central sensitization and reducing postoperative pain. Low-dose ketamine perioperatively has been associated with lower postoperative pain scores and reduced opioid consumption.
2. Regional Anesthesia Techniques • Peripheral Nerve Blocks: Techniques such as femoral nerve block (FNB), sciatic nerve block (SNB), and adductor canal block (ACB) provide effective postoperative pain relief. [13] The IPACK block (interspace between the popliteal artery and the posterior capsule of the knee) offers analgesia to the posterior knee without affecting motor function. • Local Infiltration Analgesia (LIA): Involves administering a mixture of local anesthetics and adjuvants directly into the surgical site. This technique is simple, cost-effective, and provides reliable pain relief with minimal side effects.
3. Nonpharmacological Strategies • Cryotherapy: Frequently used to reduce postoperative pain and swelling by constricting blood vessels, which limits the release of inflammatory mediators. • Physical Therapy: Essential for functional recovery, physical therapy aids in restoring mobility and strength post-surgery. • Peripheral Nerve Stimulation and Electrotherapy: Emerging techniques that involve applying mild electrical impulses to nerves to enhance analgesia and promote faster recovery.
Benefits of Multimodal Analgesia
• Implementing MMA protocols in TKA has been associated with: • Reduced Postoperative Pain: Patients experience significantly lower pain scores at rest and during movement in the immediate postoperative period. • Decreased Opioid Consumption: MMA strategies lead to a reduction in opioid use, minimizing associated side effects and risks of dependency. • Enhanced Functional Recovery: Improved pain control facilitates earlier mobilization and rehabilitation, contributing to better functional outcomes. • Shortened Hospital Stay: Effective pain management allows for quicker recovery, enabling patients to be discharged sooner. • Improved Psychological Well-being: Alleviation of pain contributes to reduced postoperative anxiety and depression, enhancing overall patient satisfaction. |