- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05269095
Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: spinal anesthesia only
Patients will receive 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.
|
Eksperimentell: spinal anesthesia and ultrasound-guided Genicular nerves block
Patients will receive 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.
|
Eksperimentell: 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.
|
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%
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 35236/1/22
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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