Chloroprocaine for Inguinal Herniorrhaphy
- Registration Number
- NCT03805503
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
- 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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Outpatients for unilateral inguinal hernia repair
- ASA I - II - III
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description chloroprocaine 1% injectable solution 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.
- Primary Outcome Measures
Name Time Method The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome 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
- Secondary Outcome Measures
Name Time Method 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 Time to micturition
Time for regression of two segments during surgery Time for regression of two segments
Time to discharge From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery Time to discharge
Patient satisfaction with anesthesia method: questionnaire postoperatively,at moment of hospital discharge measured up to 6 hours after surgery Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
Peak block height during surgery highest sensible block
Ambulation time 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
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) perioperative Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)