Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty

NCT04419701 | Completed DMC

• 1 other identifier: pain in knee arthroplasty
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction. The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• total doses of postoperative opioid consumption

  total doses of postoperative rescue morphine consumption

  postoperative first day

Secondary Outcomes (1)

• Time of the first dose of rescue analgesia

  postoperative first day

Other Outcomes (3)

• Knee range of motion

  postoperative first day

• Knee range of motion

  postoperative second day

• Knee range of motion

  postoperative third day

Study Arms (2)

periarticular infiltration group

EXPERIMENTAL

will receive intraoperative periarticular infitration consisting of 89.5 mL of normal saline, 20 mL of 5% bupivacaine and 0.5 mL of adrenaline (4.5 ugm/ml) with a concentration 1:220000 (total volume: 110 mL)

Procedure: periarticular infiltration

genicular nerve block group

EXPERIMENTAL

will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% with adrenaline 2.5 µg/ml with a concentration 1:400000 in the immediate postoperative period.

Procedure: genicular nerve block

Interventions

periarticular infiltration PROCEDURE

The cocktail will be injected at the following 7 anatomical zones as follows: Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement.

periarticular infiltration group

genicular nerve block PROCEDURE

The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.

genicular nerve block group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral knee arthroplasty surgery,
• aged more than 50 years of both genders.
• have american society of anesthesiologist physical status I-II and III.

You may not qualify if:

• Revision knee arthroplasty,
• previous surgery or trauma to knee,
• drug allergy, regular narcotic use,
• renal impairments
• hepatic impairments,
• neuromuscular diseases
• coagulopathy disorders.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: June 30, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 15, 2021
• Last Updated: February 17, 2021

Record last verified: 2020-06

Locations

EG (1)