Clinical Research Directory

Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty

Effective postoperative pain management remains a cornerstone of enhanced recovery protocols following total knee arthroplasty (TKA). Inadequate analgesia not only compromises patient satisfaction but also impedes early mobilization and rehabilitation, thereby increasing the risk of perioperative complications. Current multimodal analgesic strategies frequently incorporate regional techniques, with the adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block emerging as established modalities that provide motor-sparing analgesia. Despite their widespread adoption, the optimal local anesthetic regimen for these blocks remains undefined. While liposomal bupivacaine has garnered interest for its extended duration of action, its clinical efficacy relative to conventional local anesthetics combined with perineural adjuncts remains a subject of ongoing debate. Specifically, perineural dexamethasone and dexmedetomidine have each demonstrated the capacity to prolong the analgesic duration of ropivacaine; however, direct comparative data among these three distinct strategies-liposomal bupivacaine alone versus ropivacaine supplemented with either adjunct-are notably limited. Given the absence of head-to-head randomized trials evaluating these three clinically viable techniques, the optimal approach to maximize analgesic duration while minimizing opioid-related adverse effects remains unclear. This study therefore aims to compare the analgesic efficacy and safety profiles of liposomal bupivacaine, ropivacaine with perineural dexamethasone, and ropivacaine with perineural dexmedetomidine when administered via ACB and IPACK blocks in patients undergoing TKA.

Effect of Combined Adductor Canal and AFCN Block on Postoperative Inflammation

The aim of this thesis is to evaluate the effects of adding an anterior femoral cutaneous nerve (AFCN) block to the adductor canal block used for postoperative analgesia after total knee arthroplasty on the postoperative inflammatory response, as assessed by inflammatory biomarkers including NLR, PLR, AISI, and CAR.

Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

The goal of this clinical trial is to determine whether performing total knee replacement surgery (total knee arthroplasty, TKA) without a tourniquet is clinically equivalent to performing the procedure with a tourniquet in adults with symptomatic knee osteoarthritis. A tourniquet is commonly used during surgery to reduce bleeding and improve the surgeon's view. However, some studies suggest it may be associated with certain complications. It is currently unclear whether using a tourniquet meaningfully changes outcomes compared to not using one. This study aims to assess whether both approaches result in similar outcomes within a clinically acceptable range. The main question this study aims to answer is: Is total blood loss during surgery equivalent between TKA performed with a tourniquet and TKA performed without a tourniquet, within a predefined margin of ±100 mL? Additional questions include: Are surgical field quality, postoperative pain, functional recovery, and complication rates comparable between the two techniques? Researchers will compare: TKA performed with a pneumatic tourniquet TKA performed without a tourniquet to determine whether outcomes between the two approaches are equivalent rather than whether one is superior to the other. Participants will: Be randomly assigned to one of the two surgical groups using a computer-generated process Undergo standard total knee replacement surgery and routine perioperative care Have blood loss assessed during and after surgery Be monitored for pain, recovery of function, wound healing, and complications during hospital stay and follow-up visits This study is designed as a randomized controlled equivalence trial to determine whether both surgical approaches produce comparable outcomes within clinically acceptable limits, in a standardized local setting.

Knee Flexionater to Avoid Motion Restoring Surgery

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery. Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement. This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure? Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home. Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests. Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion. Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term. The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.

Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches

This is a single-institution, prospective, randomized study comparing the medial parapatellar and subvastus approaches in primary total knee arthroplasty using continuous, implant-based gait monitoring. Patients receiving a Zimmer Persona IQ smart implant will be followed preoperatively and through the first 30 days post-operatively, with extended follow-up to 6 months. Preoperative activity is captured using iPhone Health step-count data, while post-operative recovery is assessed using continuous tibial implant data, including step count, range of motion, cadence, walking speed, stride length, and distance. These objective metrics are correlated with PROMs. The primary outcome is daily step count. Secondary outcomes include early functional milestones, pain, and patient-reported functional scores. This study is designed to characterize early recovery trajectories and determine whether meaningful differences exist between surgical approaches.

Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty

The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.

Efficacy of Genicular Block on Total Knee Arthroplasty Surgery

The aim of this study is to investigate the postoperative pain relieving effect of preoperative genicular block in total knee arthroplasty surgery. The main questions it aims to answer are: 1. Do visual analog scale (VAS) scores decrease in patients who underwent geniculate block? 2. Does opioid consumption decrease in patients who underwent geniculate block? Researchers will compare postoperative pain in patients who received genicular block with those who did not.One group of patients will be administered 0.25% bupivacaine with the geniculate block method. The other group will not undergo any intervention. Both groups will be administered intravenous morphine for postoperative analgesia.

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.

The Effects of Mir Shakeel Teleintegrated Therapy Plan on Pain, Range of Motion, Gait, Functional Outcomes and Quality of Life in Patients Undergoing Total Knee Arthroplasty

The objective of this clinical trial is to determine the effects of a newly formed treatment protocol implemented as telerehabilitation and compare it with conventional physical therapy in patient recovery after Total Knee Arthroplasty. The main questions this study aims to answer are: Does telerehabilitation improve pain, range of motion, and gait as effectively as conventional physical therapy? Does telerehabilitation enhance exercise adherence, reduce kinesiophobia, and improve quality of life and patient satisfaction? Can a hybrid rehabilitation protocol combining both approaches optimize clinical and functional outcomes? Researcher will compare telerehabilitation-based physical therapy with traditional in-person therapy to see which method provides superior results in post-TKA recovery. Participants Will: Be adults aged 50-65 years who have undergone primary total knee arthroplasty Receive either conventional physical therapy or a telerehabilitation-based exercise plan for a defined intervention period Attend scheduled follow-up assessments to measure pain, range of motion, gait, functional performance, and satisfaction Complete validated questionnaires on quality of life, kinesiophobia, and exercise adherence Study Significance Osteoarthritis is a growing health concern in Pakistan, with prevalence rising from 2.85 million in 1990 to 8.49 million in 2021. The increasing number of TKA procedures has created a demand for accessible, cost-effective, and evidence-based rehabilitation models. Telerehabilitation offers an innovative solution by extending professional care to patients' homes, enhancing accessibility, and ensuring continuity of therapy. This study will provide locally relevant evidence and may lead to the development of a standardized rehabilitation protocol for Pakistani patients - improving recovery outcomes, reducing healthcare burden, and enhancing post-surgical quality of life Ultimately, this research seeks to strengthen evidence-based rehabilitation in Pakistan, reduce the post-surgical burden of disability, and enhance the quality of life for individuals recovering from knee arthroplasty. This RCT is based on a comparison of 2 groups. One will receive the MSTITP and other group will receive in person conventional physical therapy plan. This is based on 2 arm testing and the hypothesis is that the MSTITP is more effective in improving patient related outcomes in patients undergoing Total Knee Arthroplasty. Participants in group A will perform a specific set of exercises ( details can be provided as and when asked) in a mode as convenient for the patients. The effect of Telerehabilitation will also be evaluated. Participants in Group B will receive Conventional Physical Therapt as documented in in person sessions and will be followed for the same duration as of Patients in Group A.

Comparison of Ultrasound-Guided Lumbar ESPB and ACB for Knee Arthroplasty

Total knee arthroplasty (TKA) is a surgical procedure frequently associated with moderate-to-severe postoperative pain. While Adductor Canal Block (ACB) has demonstrated analgesic efficacy in TKA, the Erector Spinae Plane Block (ESPB) is also being utilized as part of multimodal analgesia for postoperative pain management in lower extremity surgeries. Currently, there is a gap in the literature as no studies have directly compared the efficacy of ACB and ESPB for pain management following TKA. The primary objective of this study is to compare the efficacy of these two analgesic methods in the context of postoperative analgesia management after total knee arthroplasty.

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

The goal of this observational study is to learn about the analgesic efficacy and postoperative recovery of two locoregional anesthesia combinations in patients \> 18 years (ASA I-III), scheduled for unilateral TKA under spinal anesthesia with expected hospitalization \> 24 hours: * ACB + sacral ESP block * ACB + iPACK block The main question it aims to answer is: Does the ACB + sacral ESP block combination produce effective postoperative recovery and analgesic effect? Participants already taking ACB + sacral ESP block as part of their regular peri-operative care for TKA will be followed in the postoperative period for 48 hours.

Dinalbuphine Sebacate in Postoperative Pain Control After TKA

To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty

ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

Post-operative analgesia after total knee arthroplasty (TKA) has always been a challenge in the anesthesiological setting, having to combine good pain control and the need for early mobilization, both factors that can affect the quality of rehabilitation treatment, prosthetic functional outcome, the onset of chronic pain, joint stiffness and the consequent quality of life of the patient. Recent loco-regional anesthesia (LRA) techniques have made an essential contribution to peri-operative management in the fast-track perspective of surgery, in terms of optimization of analgesia and rapid functional recovery. Inadequate post-operative analgesia, by affecting the normal rehabilitation pathway, is associated with medium-long term complications, such as chronic pain, joint stiffness and patient dissatisfaction, which often compromise functional autonomy and quality of life of the patient and may require invasive treatments (surgical revision, unlocking under general anesthesia). The local and systemic inflammatory state, evidenced by peri-operative dosage of specific biomarkers, appears to be related to prosthetic outcome.

The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery

The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty. Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

The goal of this RCT is to compare analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection. The main question\[s\] it aims to answer are: Does Intraosseous multimodal analgesic cocktail injection have more post-operative analgesic effect than Peri-articular injection in patients who have done TKA (P)? Participants will randomized to intraosseous injection group or peri-articular injection group and will record the 100-mm VAS pain scores for 2 weeks after TKA. Researchers will compare to peri-articular injection group to see pain and functional outcomes after TKA.

The Effect of Kinesio Taping on Mobility, Pain, Balance and Daily Activities in Total Knee Replacement Patients

Total knee arthroplasty (TKA) is a surgical procedure performed to relieve pain and functional limitations caused by advanced gonarthrosis that cannot be managed with conservative methods. It is known that the postoperative rehabilitation program plays a crucial role in functionality and mobility in the postoperative period. Pain and swelling are the most commonly reported minor complications that lead to functional limitations, often associated with decreased muscle strength. After TKA, various current methods such as compression therapy and electrotherapy are employed to treat postoperative edema. Typically, patients are discharged with a home exercise program once they are ambulatory. However, the return to daily living activities varies among patients, and some may experience prolonged recovery times. In our country and hospital, there is no standardized algorithm for postoperative care following TKA. Patients are often referred to rehabilitation clinics only when complications arise. Due to issues with patient ambulation, there may be a need for inpatient care following TKA. While traditional rehabilitation programs are used, alternative methods to facilitate early ambulation have emerged in recent years, one of which is kinesiology taping (KT). Developed by Kenso Kase in the 1970s, KT is an elastic, wave-textured, waterproof, breathable cotton tape applied directly to the skin. When applied with various techniques, it helps alleviate pain, reduce edema, and provides mechanical support and joint protection. KT does not restrict movement; instead, its elastic structure opens the space between the dermis and fascia, aiding lymphatic and blood flow, thereby reducing swelling in the extremities. There are studies on the use of KT in postoperative patients beyond musculoskeletal pain conditions, particularly regarding its effectiveness in managing pain, swelling, and joint range of motion after shoulder and anterior cruciate ligament surgeries. Although recent studies in the literature have explored the use of KT after TKA, there is still no consensus on its efficacy and application methods. This study aims to investigate the potential effects or complications of KT treatment on balance, pain, mobility, and quality of life in patients undergoing rehabilitation after TKA.

Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA

Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually. The definitive treatment for knee joint degeneration is total knee arthroplasty.

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.