search
Back to results

Pain Management After Adductor Canal Block for Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
0.9%sodium chloride
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring iPACK, Adductor Canal Block, pain management, multimodal analgesia, peripheral nerve block, knee arthroplasty

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients > 18 years old undergoing unilateral total knee arthroplasty Exclusion Criteria: refusal to participate < 18 yo Chronic opioid use localized infection

Sites / Locations

  • Poznan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iPACK block+ABC block

Sham blocks

Arm Description

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.

Outcomes

Primary Outcome Measures

postoperative Numeric Pain Rating Scale
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Secondary Outcome Measures

Postoperative opioid consumption
milligrams of intravenous morphine equivalents
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Time to first opioid administration
Hours to first administration of an intravenous opioid drug

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Poznan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT06086483
Brief Title
Pain Management After Adductor Canal Block for Total Knee Arthroplasty
Official Title
Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.
Detailed Description
The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy, Knee Pain Chronic
Keywords
iPACK, Adductor Canal Block, pain management, multimodal analgesia, peripheral nerve block, knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPACK block+ABC block
Arm Type
Active Comparator
Arm Description
Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.
Arm Title
Sham blocks
Arm Type
Active Comparator
Arm Description
Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Other Intervention Name(s)
Ropimol
Intervention Description
20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block
Intervention Type
Drug
Intervention Name(s)
0.9%sodium chloride
Other Intervention Name(s)
normal saline
Intervention Description
20 mL 0.9% sodium chloride was injected into the PENG block 20 mL 0.5% sodium chloride was injected into the Adductor Canal block
Primary Outcome Measure Information:
Title
postoperative Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
24 hours after surgery
Title
postoperative Numeric Pain Rating Scale et rest
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
48 hours after surgery
Title
postoperative Numeric Pain Rating Scale et rest
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
72 hours after surgery
Title
postoperative Numeric Pain Rating Scale et rest
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
96 hours after surgery
Title
postoperative Numeric Pain Rating Scale during active flexion
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
48 hours after surgery
Title
postoperative Numeric Pain Rating Scale during active flexion
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
72 hours after surgery
Title
postoperative Numeric Pain Rating Scale during active flexion
Description
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
96 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
milligrams of intravenous morphine equivalents
Time Frame
96 hours after surgery
Title
Neutrophil-to-lymphocyte ratio
Description
Neutrophil-to-lymphocyte ratio
Time Frame
12 hours after surgery
Title
Neutrophil-to-lymphocyte ratio
Description
Neutrophil-to-lymphocyte ratio
Time Frame
24 hours after surgery
Title
Platelet-to-lymphocyte ratio
Description
Platelet-to-lymphocyte ratio
Time Frame
12 hours after surgery
Title
Platelet-to-lymphocyte ratio
Description
Platelet-to-lymphocyte ratio
Time Frame
24 hours after surgery
Title
Time to first opioid administration
Description
Hours to first administration of an intravenous opioid drug
Time Frame
96 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years old undergoing unilateral total knee arthroplasty Exclusion Criteria: refusal to participate < 18 yo Chronic opioid use localized infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zbigniew Żaba, Ph.D.
Organizational Affiliation
Department of Emergency Medicine Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Malgorzata Domagalska, Ph.D.
Organizational Affiliation
Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznan
State/Province
Poznań
ZIP/Postal Code
61-701
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data presented in this study are available on request from the corresponding author.
IPD Sharing Time Frame
December 2024
IPD Sharing Access Criteria
The data presented in this study are available on request from the corresponding author.

Learn more about this trial

Pain Management After Adductor Canal Block for Total Knee Arthroplasty

We'll reach out to this number within 24 hrs