We will establish the optimal dose chloroprocaine for knee-arthroscopy
ID
Bron
Verkorte titel
Aandoening
Spinal anesthesia for knee arthroscopy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Succesfull anesthesia. Anesthesia is considered successful when:<br>
1. Complete loss of cold sensation at the L2 dermatome, AND<br>
2. Pain is 0-2 following inflation of the tourniquet and zero upon incision<br>
3. Pain is 0-3 during surgery<br>
Achtergrond van het onderzoek
In day-case surgery, spinal anesthesia with both rapid onset, a short duration of block and minimal side effects is preferred. Chloroprocaine (CP) is increasingly used for this purpose. So far, the optimal dose of chloroprocaine has not been clinically established for ambulatory knee arthroscopy regarding quick postoperative mobilization and patient comfort.
Doel van het onderzoek
We will establish the optimal dose chloroprocaine for knee-arthroscopy
Onderzoeksopzet
Sensibel block at t=2, 4, 6, 8, 10, 15, 20, 25, 30 until end of recovery
Motor block at t=5, 10, 15, 20, 25, 30, 45, 60
Pain score at inflation of the tourniquet and during surgery
Onderzoeksproduct en/of interventie
• In the first part of the study, the injected dose of chloroprocaine will be varied according to the modified up-and-down sequential allocation method (UDM) established by Dixon and Massey.14,15 The dose of chloroprocaine that a patient receives is determined by the previous patient’s response. If successful anesthesia was obtained, the next dose will be decreased. Conversely, if anesthesia was not successful, the next dose is increased. Treatment allocation will take place one day before hospital admission.
• In the second part of the study, all patients receive the ED90 dose determined in the first part. This observational section is performed with a chosen sample of patients scheduled for the same type of surgery.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Scheduled elective ambulatory knee arthroscopy
• Age >18 years
• American Society of Anesthesiology physical status I- III
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Allergy to one of the trial drugs
• Contraindication to neuraxial anesthesia
• Previous neuropathy to the lower extremities
• Pregnancy
• No informed consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6769 |
NTR-old | NTR6946 |
Ander register | VUMC : 2018.026 |