Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

Study Overview
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Brief Summary
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A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Detailed Description
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Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Official Title
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Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty

Conditions
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IPACK Block Multimodal Analgesia, Postoperative NRS Scores

Intervention / Treatment
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* Drug: Dexketoprofen Trometamol
* Other: spinal anesthesia
* Other: IPACK
* Other: PAI
* Other: Adductor canal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon Age 18 to 80 years Planned use of regional anesthesia Ability to follow study protocol Patients of participating surgeons Exclusion Criteria: Hepatic or renal insufficiency Younger than 18 years old and older than 80 Patients undergoing general anesthesia Allergy or intolerance to one of the study medications BMI > 40 Diabetes ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Power analysis will be done after a pilot study. Number of patient may vary.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-Articular Injections and IPACK<br>Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine At the end of surgery; PAI: 30 ml 0,025% bupivacaine and IPACK: 20 ml 0,025% bupivacaine | Drug: Dexketoprofen Trometamol<br>* Drug: Dexketoprofen Trometamol oral tablet<br>Other: spinal anesthesia<br>* Drug: heavy bupivacaine 2,5 ml 0,5%<br>Other: IPACK<br>* Drug: bupivacaine 20 ml 0,025%<br>Other: PAI<br>* Drug: bupivacaine 30 ml 0,025%<br>|
| Active Comparator: Adductor Canal Block, and IPACK<br>Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine At the end of surgery; ADD: 20 ml 0,025% bupivacaine and IPACK: 20 ml 0,025% bupivacaine | Drug: Dexketoprofen Trometamol<br>* Drug: Dexketoprofen Trometamol oral tablet<br>Other: spinal anesthesia<br>* Drug: heavy bupivacaine 2,5 ml 0,5%<br>Other: IPACK<br>* Drug: bupivacaine 20 ml 0,025%<br>Other: Adductor canal block<br>* Drug: bupivacaine 20 ml 0,025%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS Pain Scores | NRS Pain scores with ambulation 24 hours post block administration.All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups. | 24 hours post block administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS at Rest and with movement | NRS at rest and with movement at different intervals. All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups. | 24 hours on Post-Operative Day 1 | 
| Patient Satisfaction with Pain Control using the likert scale | Satisfaction with Pain control at different intervals. 1-5 (according to patient satisfaction) | Post-Operative 24 hours |