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CompletedNCT04419701Updated Feb 17, 2021

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

An interventional study of periarticular infiltration and genicular nerve block in Postoperative Pain, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Tanta University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic department, has been a successful intervention for patients with end-stage knee arthritis.

Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain without motor impairment, resulting in successful mobilization. Pain control plays an essential role in the overall postoperative period for the patients undergoing TKA.

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.

Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to evaluate functional recovery and the success of the type of analgesia used.

Several methods such as intravenous opioids, extraarticular and intraarticular injection, epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative pain management.

However, each method is reported with potential side effects, for example, opioid drugs caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia with urinary retention, respiratory depression and spinal headache, femoral or sciatic block with diminished muscle control and possible nerve damage.

Periarticular multimodal drug injection in TKA is a technique that patients received intraoperative drug injection in the periarticular fields such as posterior capsule, medial and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.

Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 88 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Revision knee arthroplasty,
  • previous surgery or trauma to knee,
  • drug allergy, regular narcotic use,
  • renal impairments
  • hepatic impairments,
  • neuromuscular diseases
  • coagulopathy disorders.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    periarticular infiltration group

    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

  • Experimental
    genicular nerve block group

    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

  • Procedureperiarticular infiltration

    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.

  • Proceduregenicular nerve block

    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.

06

What researchers measure

Primary outcomes

  1. total doses of postoperative opioid consumption

    total doses of postoperative rescue morphine consumption

    Time frame: postoperative first day

Secondary outcomes

  1. Time of the first dose of rescue analgesia

    Time of the first dose of rescue morphine analgesia at dose of 3 mg

    Time frame: postoperative first day

Other outcomes

  1. Knee range of motion

    The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees

    Time frame: postoperative first day

  2. Knee range of motion

    The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees

    Time frame: postoperative second day

  3. Knee range of motion

    The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees

    Time frame: postoperative third day

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Study locations

1 site
  • Tarek Abdel Hay
    Tanta, El Gharbyia 31527, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04419701
Lead sponsor
Tanta University
Responsible party
tarek abdel hay mostafa (principle investigator, Tanta University) — Principal investigator
First posted
Jun 5, 2020
Start date
Jun 30, 2020
Primary completion
Dec 30, 2020
Completion
Jan 15, 2021
Last update
Feb 17, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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