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

16. februar 2021 oppdatert av: tarek abdel hay mostafa, Tanta University

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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

88

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31527
        • Tarek Abdel Hay

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)

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.

Eksperimentell: 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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
total doses of postoperative opioid consumption
Tidsramme: postoperative first day
total doses of postoperative rescue morphine consumption
postoperative first day

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time of the first dose of rescue analgesia
Tidsramme: postoperative first day
Time of the first dose of rescue morphine analgesia at dose of 3 mg
postoperative first day

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee range of motion
Tidsramme: postoperative first day
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
postoperative first day
Knee range of motion
Tidsramme: postoperative second day
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
postoperative second day
Knee range of motion
Tidsramme: postoperative third day
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
postoperative third day

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2020

Primær fullføring (Faktiske)

30. desember 2020

Studiet fullført (Faktiske)

15. januar 2021

Datoer for studieregistrering

Først innsendt

3. juni 2020

Først innsendt som oppfylte QC-kriteriene

3. juni 2020

Først lagt ut (Faktiske)

5. juni 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. februar 2021

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • pain in knee arthroplasty

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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