Chloroprocaine for Inguinal Herniorrhaphy

Spinal Anesthesia Clinical Trial

Official title:

Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805503
• Other study ID #: EC/2014/1264
• Status: Completed
• Phase: Phase 4
• Start date: September 16, 2015
• Est. completion date: December 4, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 4, 2018
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• Chloroprocaine 1% Injectable Solution
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome	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	Peak block height	highest sensible block	during surgery
Secondary	Time for regression of two segments	Time for regression of two segments	during surgery
Secondary	Ambulation time	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
Secondary	Time to micturition	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
Secondary	Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)	Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)	perioperative
Secondary	Time to discharge	Time to discharge	From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
Secondary	Patient satisfaction with anesthesia method: questionnaire	Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)	postoperatively,at moment of hospital discharge measured up to 6 hours after surgery