Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

IPACK Block Multimodal Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213287
• Other study ID #: 70/13
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: December 2019
• Source: Ankara Diskapi Training and Research Hospital
• Contact: ilkay MD Baran akkus, MD
• Phone: 0905323852642
• Email: ilkayb[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 15, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• IPACK Block Multimodal Analgesia
• Postoperative NRS Scores

Intervention

Drug:
• Dexketoprofen Trometamol
Drug: Dexketoprofen Trometamol oral tablet

Other:
• spinal anesthesia
Drug: heavy bupivacaine 2,5 ml 0,5%
• IPACK
Drug: bupivacaine 20 ml 0,025%
• PAI
Drug: bupivacaine 30 ml 0,025%
• Adductor canal block
Drug: bupivacaine 20 ml 0,025%

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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