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Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy

8. marts 2022 opdateret af: Muhammad Ahmed Kandil, Tanta University

Analgesic Effect of Adductor Canal Block Combined With Infiltration of the Interspace Between Popliteal Artery and the Capsule of the Knee (IPACK) Block Versus Genicular Nerves Block in Knee Arthroscopy

This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Maintaining patient safety, ensuring best patient outcomes, and optimal pain relief post-operatively are of utmost concern for anesthesia providers. Adequate pain relief attenuates stress responses and long-term chronic pain complications while contributing to improved postoperative outcomes.

Knee arthroscopy is a very common procedure and very often is performed as day-case surgery. Ambulatory arthroscopic surgery of the knee is preferred by the majority of properly selected and well-informed patients. It has been reported that a significant number of patients have moderate to severe pain 24 hours after ambulatory surgery in general and knee arthroscopy in particular and pain affects the patient's activity level and satisfaction. Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease the pain significantly and decrease opioid consumption with minimal effect on quadriceps function. It provides analgesia to the peri-articular and intra-articular aspects of the knee joint but doesn't relieve posterior knee pain which is moderate to severe in intensity.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

105

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 21-60 years
  • Both genders
  • American Society of Anaesthesiologists physical status classification I - III
  • Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia

Exclusion Criteria:

  • Patient refusal
  • Preoperative neurological deficits
  • Opioid-dependent (opioid intake more than 3 months)
  • Chronic pain conditions
  • Significant cardiac and respiratory disease
  • Pre-existing major organ dysfunction such as hepatic and renal failure
  • Coexisting hematological disorder or deranged coagulation parameters
  • Psychiatric illnesses
  • Allergy to any of the drugs used in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: spinal anesthesia only
Patients will receive spinal anesthesia only
Procedure: Spinal anesthesia only
Patients will receive spinal anesthesia with 2-3 ml 0.5% (10-15 mg) hyperbaric bupivacaine plus 25 ug fentanyl at the L3/4 interspaces.
Eksperimentel: spinal anesthesia and ultrasound-guided Genicular nerves block
Patients will receive spinal anesthesia and ultrasound-guided Genicular nerves block
Biologisk: Spinal anesthesia and ultrasound-guided Genicular nerves block
Patients will receive16 ml bupivacaine 0025% will be administered, and4 ml of this solution will be placed at each of the 4 target nerves.
Eksperimentel: Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace
Patients will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block plus infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (PACK) block.
Biologisk: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)
Adductor Canal block (ACB) technique will be performed using 16 ml bupivacaine 0025% As regarding the Popliteal artery and the capsule of posterior knee block ('PACK), it will be performed Using 16 ml bupivacaine 0.25%

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative 24-hour rescue analgesic consumption
Tidsramme: 24 hours postoperative
Total postoperative 24-hour rescue analgesic consumption will be recorded
24 hours postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-operative pain
Tidsramme: 24 hours Postoperative
Post-operative pain will be assessed by the Numeric Rating Scale (NRS) rest and mobilization.
24 hours Postoperative
Time taken till 1st rescue analgesic request
Tidsramme: 24 hours Postoperative
The time till administration of first rescue analgesia will be recorded
24 hours Postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

21. marts 2022

Primær færdiggørelse (Forventet)

20. marts 2023

Studieafslutning (Forventet)

21. marts 2023

Datoer for studieregistrering

Først indsendt

4. marts 2022

Først indsendt, der opfyldte QC-kriterier

4. marts 2022

Først opslået (Faktiske)

7. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 35236/1/22

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available under a reasonable request from the corresponding author

IPD-delingstidsramme

One year after the end of the study

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Spinal anesthesia only

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Spain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner