Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

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

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).

Study Overview

• Status: Unknown
• Conditions: IPACK Block Multimodal Analgesia; Postoperative NRS Scores
• Intervention / Treatment: Drug: Dexketoprofen Trometamol; Other: spinal anesthesia; Other: IPACK; Other: PAI; Other: Adductor canal block

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındag
    • Ankara, Altındag, Turkey, 06450
      • Recruiting
      • Diskapi Yildirim Beyazit Training Research Hospital
      • Contact: ilkay baran, md; Phone Number: 5323852642; Email: ilkayb@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peri-Articular Injections and IPACK; 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; Drug: Dexketoprofen Trometamol oral tablet; Other: spinal anesthesia; Drug: heavy bupivacaine 2,5 ml 0,5%; Other: IPACK; Drug: bupivacaine 20 ml 0,025%; Other: PAI; Drug: bupivacaine 30 ml 0,025%
Active Comparator: Adductor Canal Block, and IPACK; 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; Drug: Dexketoprofen Trometamol oral tablet; Other: spinal anesthesia; Drug: heavy bupivacaine 2,5 ml 0,5%; Other: IPACK; Drug: bupivacaine 20 ml 0,025%; Other: Adductor canal block; Drug: bupivacaine 20 ml 0,025%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital
• Investigators: Principal Investigator: Ilkay MD Baran Akkuş, MD, Diskapi Yildirim Beyazit Training Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 15, 2020

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dexketoprofen trometamol
• Other Study ID Numbers: 70/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No