To determine the effective dose ED90 of Chloroprocaine for patients undergoing knee arthroscopy.
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful 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 (Transient Neurologic Syndrom)
Urine retention
Patient satisfaction
Background summary
In day case lower limb surgery, spinal anaesthesia with both rapid onset and a
short duration of block is preferable. A short acting spinal anaesthetic
facilitates a smooth patient flow: quick recovery of motor function will
facilitate unassisted ambulation.
In the Netherlands chloroprocaine is expected to be licensed in 2017. From that
point, chloroprocaine and prilocaine will be the only two short acting
anaesthetics with a license for spinal administration in the Netherlands. 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
To determine the effective dose ED90 of Chloroprocaine for patients undergoing
knee arthroscopy.
Study design
prospective double blind
Intervention
In the first part of the study, the injected dose op CP will be varied
according to the a Biased-Coin-Up-and-Down sequential allocation
The dose of CP that a patient receives is determined by the previous patient*s
response. If successful anesthesia was obtained, the next patient*s dose will
be the same or decreased with 5 mg. Conversely, if anesthesia was not
successful, the next patient*s dose is the same of increased with 5 mg. 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.
Study burden and risks
The risk for an individual trial participant is expected to be very low because
the trial
drug is licensed for the purpose we will use it for. However, as a consequence
of the study design there will be a number of patients with an insufficient
block. To prevent unnecessary pain or discomfort for the patient, start- and
stopcriteria for the study procedure are defined. For occurrences of
inadequate analgesia, patients will receive additional analgetics.
De Boelenlaan 1117
Amsterdam 1081 HV
NL
De Boelenlaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Scheduled ambulatory knee arthroscopy;
Age * 18 years;
ASA physical status I-III
Exclusion criteria
Allergy to chloroprocaine;
Contraindication to neuraxial anaesthesia;
Allergy to local anesthetics of the ester-type: cocaine, oxybuprocaine, procaine, tetracaine.
Allergy to parabens or paraaminobenzoic-acid (PABA)
Pseudocholinesterase deficiency
Previous neuropathy to the lower extremities;
Pregnancy;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002559-27-NL |
| CCMO | NL61905.029.17 |