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Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

Primary Purpose

IPACK Block Multimodal Analgesia, Postoperative NRS Scores

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dexketoprofen Trometamol
spinal anesthesia
IPACK
PAI
Adductor canal block
Sponsored by
Ankara Diskapi Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IPACK Block Multimodal Analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Diskapi Yildirim Beyazit Training Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peri-Articular Injections and IPACK

Adductor Canal Block, and IPACK

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Patient Satisfaction with Pain Control using the likert scale
Satisfaction with Pain control at different intervals. 1-5 (according to patient satisfaction)

Full Information

First Posted
December 23, 2019
Last Updated
December 25, 2019
Sponsor
Ankara Diskapi Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04213287
Brief Title
Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty
Official Title
Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IPACK Block Multimodal Analgesia, Postoperative NRS Scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Power analysis will be done after a pilot study. Number of patient may vary.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peri-Articular Injections and IPACK
Arm Type
Experimental
Arm Description
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
Arm Title
Adductor Canal Block, and IPACK
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol
Intervention Description
Drug: Dexketoprofen Trometamol oral tablet
Intervention Type
Other
Intervention Name(s)
spinal anesthesia
Intervention Description
Drug: heavy bupivacaine 2,5 ml 0,5%
Intervention Type
Other
Intervention Name(s)
IPACK
Intervention Description
Drug: bupivacaine 20 ml 0,025%
Intervention Type
Other
Intervention Name(s)
PAI
Intervention Description
Drug: bupivacaine 30 ml 0,025%
Intervention Type
Other
Intervention Name(s)
Adductor canal block
Intervention Description
Drug: bupivacaine 20 ml 0,025%
Primary Outcome Measure Information:
Title
NRS Pain Scores
Description
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.
Time Frame
24 hours post block administration
Secondary Outcome Measure Information:
Title
NRS at Rest and with movement
Description
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.
Time Frame
24 hours on Post-Operative Day 1
Title
Patient Satisfaction with Pain Control using the likert scale
Description
Satisfaction with Pain control at different intervals. 1-5 (according to patient satisfaction)
Time Frame
Post-Operative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ilkay MD Baran akkus, MD
Phone
0905323852642
Ext
0903125902000
Email
ilkayb@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilkay MD Baran Akkuş, MD
Organizational Affiliation
Diskapi Yildirim Beyazit Training Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training Research Hospital
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilkay baran, md
Phone
5323852642
Email
ilkayb@hotmail.com

12. IPD Sharing Statement

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Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

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