Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Phase 3

Completed

• Conditions: Spinal Anesthesia

• Registration Number: NCT00332735
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.

Detailed Description

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.

Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected.

Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine.

Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.

Endpoints are:

* onset of sensory and motor block

* maximum spread of sensory level

* recovery from sensory and motor block

* time to micturition

* complications

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-02
• Study Completion: 2007-01
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-18
• Last Update Posted: 2007-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age between 18 and 70 years
• Patients planned for an outpatient lower limb surgery
• Procedure under spinal anesthesia
• Informed consent

Exclusion Criteria

• Contra-indications spinal anesthesia
• History of allergic reactions on amide-type local anesthetics
• Length < 1.60 m or > 1.90 m
• BMI < 18.5 kg/m2 or > 35 kg/m2
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recovery time from motor blockade

Secondary Outcome Measures

Name	Time	Method
onset of sensory and motor blockade
maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
spread of sensory blockade after 1,5 hour
recovery time from sensory blockade
time to micturation
complications

Trial Locations

Locations (1)

Reinier de Graaf Groep; 🇳🇱 Voorburg, Zuid-Holland, Netherlands