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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  
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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,  
 
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. 
 
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
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
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.
 
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