- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805503
Chloroprocaine for Inguinal Herniorrhaphy
Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.
The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Outpatients for unilateral inguinal hernia repair
- ASA I - II - III
Exclusion Criteria:
- hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
- contraindications to spinal or epidural anesthesia
- bilateral inguinal herniorrhaphy
- extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chloroprocaine 1% injectable solution
Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%. An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study. An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study. |
standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg. Efficacy of the analgesia will be evaluated: Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
Time Frame: start of surgery
|
MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery
|
start of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak block height
Time Frame: during surgery
|
highest sensible block
|
during surgery
|
Time for regression of two segments
Time Frame: during surgery
|
Time for regression of two segments
|
during surgery
|
Ambulation time
Time Frame: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
|
motor recovery
|
From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
|
Time to micturition
Time Frame: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
|
Time to micturition
|
From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
|
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
Time Frame: perioperative
|
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
|
perioperative
|
Time to discharge
Time Frame: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
|
Time to discharge
|
From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
|
Patient satisfaction with anesthesia method: questionnaire
Time Frame: postoperatively,at moment of hospital discharge measured up to 6 hours after surgery
|
Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
|
postoperatively,at moment of hospital discharge measured up to 6 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aliaksandra Parashchanka, MD, stafmember department of Anesthesiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2014/1264
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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