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ID
Source
Brief title
Health condition
Spinal anesthesia for knee arthroscopy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Succesfull anesthesia. Anesthesia is considered successful when:
1. Complete loss of cold sensation at the L2 dermatome, AND
2. Pain is 0-2 following inflation of the tourniquet and zero upon incision
3. Pain is 0-3 during surgery
Secondary outcome
- Motor block
- TNS
- Urine retention
- Patient satisfaction
Background summary
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.
Study objective
We will establish the optimal dose chloroprocaine for knee-arthroscopy
Study design
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
Intervention
• 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.
Inclusion criteria
• Scheduled elective ambulatory knee arthroscopy
• Age >18 years
• American Society of Anesthesiology physical status I- III
Exclusion criteria
• Allergy to one of the trial drugs
• Contraindication to neuraxial anesthesia
• Previous neuropathy to the lower extremities
• Pregnancy
• No informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6769 |
| NTR-old | NTR6946 |
| Other | VUMC : 2018.026 |