Comparing Local Anesthesia With and Without iPACK Block

NCT04635176 | Unknown Phase 4 DMC

• 1 other identifier: "REB20-1633"
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• Comparing pain scores using the visual analogue scale between 2 groups

  Visual analogue scale is a tool to measure intensity of pain in human. It is numeric (0-100);A higher score indicates greater pain intensity.

  4 hours after surgery

• Comparing pain scores using the visual analogue scale between 2 groups

  Visual analogue scale is a tool to measure intensity of pain in human. It is numeric (0-100);A higher score indicates greater pain intensity.

  24 hours after surgery

• Comparing total opioid consumption between 2 groups

  Opioid consumption will be compared between two groups by measuring how many milligrams opioids patients consume in each group, the total dose of opioids consumed by patients will be converted to oral morphine dose equivalents in milligrams, and this mg value will be compared between the groups. The opioid can refer to morphine or oxycodone or hydromorphone or codeine any kind of opioid-type medication. There is a standard conversion of any other opioid potency to "morphine equivalents" (eg: hydromorphone is 5x more potent than morphine).

  During 24 hours after surgery

• Comparing total length of hospital stay

  Comparing total length of hospital stay

  20-48 hours after surgery

• Timed Up and Go test results

  Timed Up and Go test results

  pre-intervention

• Timed Up and Go test results

  Timed Up and Go test results

  Up to 24 hours after surgery

• Comparing knee Range of Motion (ROM)

  Comparing knee Range of Motion (ROM)

  pre-intervention

• Comparing knee Range of Motion (ROM)

  Comparing knee Range of Motion (ROM)

  Up to 24 hours after surgery

• Comparing patient satisfaction using Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The WOMAC is a patient reported outcome questionnaire, consisting 24 items divided into three subscales: 1) Pain (5 items), 2) Stiffness (2 items) and 3) Physical Function (17 items). A total WOMAC score is created by summing the items for all three subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Previous assessment has supported the internal consistency of the WOMAC subscale.

  Up to 24 hours after surgery

• Comparing patient satisfaction using Knee Society Scoring (KSS)

  The Knee Society Scoring system is both physician and patient-derived. It includes versions to be administered pre-operatively and post-operatively. It has an initial assessment of demographic details, including an expanded Charnley Functional classification. The objective knee score, completed by surgeon, includes a Visual Analogue Scale score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and Range Of Motion. The KSS System is a validated instrument based on surgeon and patient generated data, adapted to the diverse lifestyles and activities. The greater score associated with higher satisfaction.

  Up to 24 hours after surgery

Secondary Outcomes (5)

• Number pf participants returning to emergency room in the hospital

  Within 30 days after surgery

• Incidence of the unanticipated motor block from iPACK intervention by a questionnaire filled out by the attending anesthesiologist

  Up to 24 hours after surgery

• Incidence of other unanticipated complications of iPACK intervention by a questionnaire filled out by the attending anesthesiologist

  Up to 24 hours after surgery

• Incidence of technical difficulties experienced by a questionnaire filled out by the attending anesthesiologist on the day of surgery

  24 hours after surgery

• Comparing duration (in minutes) of tourniquet use during surgery between two groups

  During surgery time

Study Arms (2)

Sham iPACK block

PLACEBO COMPARATOR

This groups will receive the adductor canal block with the local anesthetic (15 mL of 0.25% bupivacaine + 2.5 mcg/mL epinephrine + 50 mcg/mL preservative-free dexamethasone) and local infiltration of analgesia+ sham iPACK block with 20 mL of normal saline.

Drug: Sham iPACK block with 20ml normal saline

Real IPACK block.

ACTIVE COMPARATOR

This groups will receive the adductor canal block with the local anesthetic (15 mL of 0.25% bupivacaine + 2.5 mcg/mL epinephrine + 50 mcg/mL preservative-free dexamethasone) and local infiltration of analgesia + real iPACK block with 20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone

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

Interventions

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

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

Also known as: real iPACK block with local anesthesia

Real IPACK block.

Sham iPACK block with 20ml normal saline DRUG

Sham iPACK block with 20 ml Normal saline

Also known as: sham iPACK block with Normal saline

Sham iPACK block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective unilateral TKA
• Planned for regional anesthesia for the procedure
• Age \>=18

You may not qualify if:

• Contraindications to regional anesthesia or peripheral nerve blocks
• Allergy to local anesthetics or any of the study medications
• Severe hepatic or renal insufficiency
• Chronic opioid consumption
• Patient with difficulty comprehending visual analogue scale pain scores
• Pre-existing lower extremity neurologic abnormalities
• Patients classified as American Society of Anesthesiologists score 3 or 4
• Language/communication barrier

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator
• Alberta Hip and Knee Clinic: collaborator

Study Sites (1)

University of Calgary/AB Hip and Knee Clinic

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Anesthesia, Local; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rajrishi Sharma, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajrishi Sharma, MD

CONTACT

403-221-4315; rajrishi.sharma@ucalgary.ca

Teresa Nguyen, BSc

CONTACT

403-536-3725; thlnguye@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study personnel, including research team, anesthesiologists, surgeons, physiotherapists, recovery room and ward nurses, as well as patients will be blinded to the group allocation. Anesthesia assistants not involved in study data collection or patient care will prepare the sham or real local anesthetic injectate solution for iPACK block. Syringes will be prepared immediately after randomization and before block placement and provided to the blinded anesthesiologist. The statistician who run randomization would only know study IDs and stay blinded to patients' treatment arms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Group A will receive perioperative ACB, LIA, and sham IPACK block. Group B will receive perioperative ACB, LIA, and real IPACK block.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 18, 2020
• Study Start: October 30, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)