Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04213287
Collaborator
(none)
70
1
2
2.7
25.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexketoprofen Trometamol
  • Other: spinal anesthesia
  • Other: IPACK
  • Other: PAI
  • Other: Adductor canal block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Power analysis will be done after a pilot study. Number of patient may vary.Power analysis will be done after a pilot study. Number of patient may vary.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty
Actual Study Start Date :
Dec 23, 2019
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Mar 15, 2020

Arms and Interventions

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%

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Yildirim Beyazit Training Research Hospital Ankara Altındag Turkey 06450

Sponsors and Collaborators

  • Ankara Diskapi Training and Research Hospital

Investigators

  • Principal Investigator: Ilkay MD Baran Akkuş, MD, Diskapi Yildirim Beyazit Training Education Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ilkay baran akkuş, Principal Investigator, Ankara Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04213287
Other Study ID Numbers:
  • 70/13
First Posted:
Dec 30, 2019
Last Update Posted:
Dec 30, 2019
Last Verified:
Dec 1, 2019
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2019