Pain Management After Adductor Canal Block for Total Knee Arthroplasty

Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy; Knee Pain Chronic
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: 0.9%sodium chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• refusal to participate
• < 18 yo
• Chronic opioid use
• localized infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iPACK block+ABC block; 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.	Drug: Ropivacaine 0.2% Injectable Solution; 20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block; Other Names: Ropimol
Active Comparator: Sham blocks; 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.	Drug: 0.9%sodium chloride; 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; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	24 hours after surgery
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")	48 hours after surgery
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")	72 hours after surgery
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")	96 hours after surgery
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")	48 hours after surgery
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")	72 hours after surgery
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")	96 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	24 hours after surgery
Postoperative opioid consumption	milligrams of intravenous morphine equivalents	96 hours after surgery
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	12 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	12 hours after surgery
Time to first opioid administration	Hours to first administration of an intravenous opioid drug	96 hours postoperatively

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Zbigniew Żaba, Ph.D., Department of Emergency Medicine Clinic; Principal Investigator: Malgorzata Domagalska, Ph.D., Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: knee arthroplasty; pain management; Adductor Canal Block; multimodal analgesia; iPACK; peripheral nerve block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 495/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No