Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

Not Applicable

• Conditions: IPACK Block Multimodal Analgesia; Postoperative NRS Scores
• Interventions: Drug: Dexketoprofen Trometamol; Other: spinal anesthesia; Other: IPACK; Other: PAI; Other: Adductor canal block

• Registration Number: NCT04213287
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-23
• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-25
• Study First Posted: 2019-12-30
• Last Update Posted: 2019-12-30
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-Articular Injections and IPACK	spinal anesthesia	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
Peri-Articular Injections and IPACK	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
Peri-Articular Injections and IPACK	PAI	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
Adductor Canal Block, and IPACK	spinal anesthesia	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
Adductor Canal Block, and IPACK	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
Adductor Canal Block, and IPACK	Adductor canal block	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
Peri-Articular Injections and IPACK	Dexketoprofen Trometamol	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
Adductor Canal Block, and IPACK	Dexketoprofen Trometamol	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

Primary Outcome Measures

Name	Time	Method
NRS Pain Scores	24 hours post block administration	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.

Secondary Outcome Measures

Name	Time	Method
NRS at Rest and with movement	24 hours on Post-Operative Day 1	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.
Patient Satisfaction with Pain Control using the likert scale	Post-Operative 24 hours	Satisfaction with Pain control at different intervals. 1-5 (according to patient satisfaction)

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training Research Hospital; 🇹🇷 Ankara, Altındag, Turkey