Efficacy of iPACK After Unilateral TKA

NCT04565093 | Completed DMC

• 1 other identifier: IRB PROJECT NO. E-20-4819
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is a common orthopedic procedure associated with severe postoperative pain which may limit patient rehabilitation and hospital discharge. Although various analgesic techniques have been proposed, there is currently no consensus on the optimal protocol to improve functional outcomes following TKA. The ideal analgesic regimen post TKA should enable adequate pain control, early mobilization and physical therapy, shorten hospital stay, reduce the risk of postoperative complications and improve patient satisfaction. Our hypothesis is iPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) peripheral nerves anesthetic block is superior to Periarticular local Infiltration Analgesia (LIA)which is commonly given by the surgeons during the TKA in terms of pain relief and early mobilization.

Conditions

Arthroplasty Complications; Pain, Joint; Arthritis Knee; Regional Anesthesia Morbidity

Keywords

Knee arthroplasty; Pain control; iPACK; Local infiltration analgesia; Early rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from preoperative pain score after TKA

  The pain will assessed by numerical rating scale (NRS). From 0 to 10, with 0 being no pain and 10 being the worst pain imaginable

  Through study completion, an average of 3 days

Secondary Outcomes (2)

• Knee range of motion (ROM)

  Through study completion, an average of 3 days

• Timed-up and go (TUG)

  Through study completion, an average of 3 days

Other Outcomes (1)

• Any other adverse event related to peripheral nerve blocks

  Through study completion, an average of 3 days

Study Arms (2)

iPACK

EXPERIMENTAL

In this group, participants will receive a peripheral nerve anesthetic block that is iPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) to cover posterior knee pain after total knee arthroplasty (TKA). This anesthetic block will be performed by assigned anesthesiologist under ultrasound guidance.

Procedure: iPACK

Periarticular local infiltration analgesia (LIA)

PLACEBO COMPARATOR

In this group, participants will receive a mixture of bupivacaine 0.25% 20 ml + epinephrine 100 mics ± lornoxicam 8 mg ± morphine 10 mg ± tranexamic acid 1 gm in 40 ml normal saline (NS) that will be injected into the posterior capsule and the medial and lateral ligaments just before implantation: after insertion of the implants and into the capsule and retinacular tissues. The remaining solution (approximately 20 mL) will be used to infiltrate the muscle and subcutaneous tissues. This local anesthetic infiltration is commonly performed by the operating orthopedic surgeon during TKA for postoperative pain control.

Procedure: Periarticular local infiltration analgesia (LIA)

Interventions

iPACK PROCEDURE

Interspace between the popliteal artery and the capsule of the posterior knee (iPACK): This is basically ultrasound guided peripheral nerve block performed by the anesthesiologists at the posterior side of the knee to control pain after TKA.

iPACK

Periarticular local infiltration analgesia (LIA) PROCEDURE

A mixture of Bupivacaine 0.25% 20 ml + epinephrine 100 mics ± lornoxicam 8 mg ± morphine 10 mg ± tranexamic acid 1 gm in 40 ml normal saline (NS) will be injected into the posterior capsule and the medial and lateral ligaments just before implantation: after insertion of the implants and into the capsule and retinacular tissues. The remaining solution (approximately 20 mL) will be used to infiltrate the muscle and subcutaneous tissues. This intervention is commonly performed by the operating orthopedic surgeon to control pain after TKA.

Periarticular local infiltration analgesia (LIA)

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologist (ASA) physical status score I-III
• Scheduled for elective unilateral TKA
• Age \> 18 \< 80 years
• BMI \< 40 kg/m2

You may not qualify if:

• American Society of Anesthesiologist (ASA) physical status score (ASA) IV
• Patient scheduled for revision of TKA
• Rheumatoid Arthritis patient
• Prior back surgery
• Patients on any anticoagulant
• Any other contra-indication for spinal anesthesia

Sponsors & Collaborators

• King Khalid University Hospital: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, 7805, Saudi Arabia

Location

Related Publications (7)

• YaDeau JT, Cahill JB, Zawadsky MW, Sharrock NE, Bottner F, Morelli CM, Kahn RL, Sculco TP. The effects of femoral nerve blockade in conjunction with epidural analgesia after total knee arthroplasty. Anesth Analg. 2005 Sep;101(3):891-895. doi: 10.1213/01.ANE.0000159150.79908.21.

  PMID: 16116010 RESULT

• Fine PG. Long-term consequences of chronic pain: mounting evidence for pain as a neurological disease and parallels with other chronic disease states. Pain Med. 2011 Jul;12(7):996-1004. doi: 10.1111/j.1526-4637.2011.01187.x.

  PMID: 21752179 RESULT

• Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.

  PMID: 27171822 RESULT

• Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.

  PMID: 23788068 RESULT

• Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.

  PMID: 27627711 RESULT

• Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.

  PMID: 25376972 RESULT

• Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.

  PMID: 29026354 RESULT

Related Links

• King Khalid University Hospital

MeSH Terms

Conditions

Arthralgia; Agnosia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Abdul Sattar Narejo, FCPS, FCAI

  King Saud University College of Medicine and King Khalid University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The data will be collected by the care provider (nurses \& assistant anesthetists) and outcome assessors (physiotherapists) who will be unaware of group allocation and will record their findings in the patient's file and on a predesigned form. Patient's demographic data, duration of surgery, tourniquet time, PACU stay, postoperative heart rate, mean arterial pressure, pain score, knee range of motion (ROM), time-up-go (TUG), time to hospital discharge, patient and surgeon satisfaction, and any complication will be recorded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Model Details: This study is conducted to evaluate posterior knee pain after unilateral Total Knee Arthroplasty (TKA) comparing iPACK (Interspace between the popliteal artery and the capsule of the posterior knee) and Periarticular Local Infiltration Analgesia (LIA) under spinal anesthesia. All patients will receive Adductor Canal Block (ACB) to cover pain from anteromedial aspect of knee. 169 adult patients will be recruited in this study and will be divided into two groups; group-1 iPACK (n=85) will receive Adductor Canal Block (ACB) + iPACK and group 2 LIA (n=84) will receive ACB+ periarticular Local Infiltration Analgesia (LIA). The primary outcome, severity of pain (NRS) will be evaluated in Post Anesthesia Care Unit (PACU). The secondary outcome, time to mobilization (ROM and TUG tests) along with pain score will be recorded in the ward after 2 hours of surgery then every 12 hours until the patient discharged home.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 25, 2020
• Study Start: September 28, 2020
• Primary Completion: March 24, 2021
• Study Completion: March 27, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD will be available starting from January 2022 to December 2022
• Access Criteria: The IPD study protocol and statistical analysis will be accessible on request by email to the principal investigator.

Locations

SA (1)