Comparing Local Anesthesia With and Without iPACK Block

NCT04635176 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-10

No results posted yet for this study

Summary

Total knee arthroplasty is an effective surgical intervention for patients with chronic osteoarthritis commonly performed worldwide. Postoperative pain management has been a key focus in patient care for this procedure. Poorly controlled pain following total knee arthroplasty is associated with decreased ambulation, increased length of hospital stay, increased complications (particularly related to significant opioid use), and overall suboptimal patient recovery. Appropriate postoperative pain management utilizing motor sparing peripheral nerve blocks and periarticular injections has been shown to provide faster, more optimized patient recovery and reduced hospital length of stay in patients undergoing total knee arthroplasty.

Adductor canal block (ACB) is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty. ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1. In addition, perioperative local infiltration analgesia (LIA) performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty.

The Infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty, performed under ultrasound guidance. It targets the articular branches of the tibial, common peroneal, and obturator nerves in the popliteal region, and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty.

This study aims to determine whether the IPACK block provides additional analgesia (in combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that have reasonable existing evidence.

Conditions

  • Osteo Arthritis Knee
  • Analgesia
  • Pain, Postoperative

Interventions

DRUG

Real iPACK block (20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone)

real iPACK block with 20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone

DRUG

Sham iPACK block with 20ml normal saline

Sham iPACK block with 20 ml Normal saline

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER
  • Alberta Hip and Knee Clinic

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • Rajrishi Sharma, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635176 on ClinicalTrials.gov