Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

NCT04213287 | Unknown

• 1 other identifier: 70/13
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

IPACK Block Multimodal Analgesia; Postoperative NRS Scores

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NRS at Rest and with movement

  24 hours on Post-Operative Day 1

• Patient Satisfaction with Pain Control using the likert scale

  Post-Operative 24 hours

Study Arms (2)

Peri-Articular Injections and IPACK

EXPERIMENTAL

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; Other: spinal anesthesia; Other: IPACK; Other: PAI

Adductor Canal Block, and IPACK

ACTIVE COMPARATOR

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; Other: spinal anesthesia; Other: IPACK; Other: Adductor canal block

Interventions

Dexketoprofen Trometamol DRUG

Drug: Dexketoprofen Trometamol oral tablet

Adductor Canal Block, and IPACK; Peri-Articular Injections and IPACK

spinal anesthesia OTHER

Drug: heavy bupivacaine 2,5 ml 0,5%

Adductor Canal Block, and IPACK; Peri-Articular Injections and IPACK

IPACK OTHER

Drug: bupivacaine 20 ml 0,025%

Adductor Canal Block, and IPACK; Peri-Articular Injections and IPACK

PAI OTHER

Drug: bupivacaine 30 ml 0,025%

Peri-Articular Injections and IPACK

Adductor canal block OTHER

Drug: bupivacaine 20 ml 0,025%

Adductor Canal Block, and IPACK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazit Training Research Hospital

Ankara, Altındag, 06450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

dexketoprofen trometamol; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ilkay MD Baran Akkuş, MD

  Diskapi Yildirim Beyazit Training Education Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ilkay MD Baran akkus, MD

CONTACT

0905323852642; ilkayb@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Power analysis will be done after a pilot study. Number of patient may vary.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: December 23, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 15, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

TU (1)