MedDataX Logo

Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

NCT ID: NCT00332735

Last Updated: 2007-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spinal administration of articaine

Intervention Type DRUG

spinal administration of bupivacaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reinier de Graaf Groep

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tessa Dijkstra, drs

Role: PRINCIPAL_INVESTIGATOR

Reinier de Graaf Groep

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Reinier de Graaf Groep

Voorburg, South Holland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.

Reference Type BACKGROUND
PMID: 15966499 (View on PubMed)

Alston RP. Spinal anaesthesia with 0.5% bupivacaine 3 ml: comparison of plain and hyperbaric solutions administered to seated patients. Br J Anaesth. 1988 Oct;61(4):385-9. doi: 10.1093/bja/61.4.385.

Reference Type BACKGROUND
PMID: 3190969 (View on PubMed)

Axelsson KH, Widman GB, Sundberg AE, Hallgren S. A double-blind study of motor blockade in the lower limbs. Studies during spinal anaesthesia with hyperbaric and glucose-free 0.5% bupivacaine. Br J Anaesth. 1985 Oct;57(10):960-70. doi: 10.1093/bja/57.10.960.

Reference Type BACKGROUND
PMID: 4041323 (View on PubMed)

Kaukinen S, Eerola R, Eerola M, Kaukinen L. A comparison of carticaine and lidocaine in spinal anaesthesia. Ann Clin Res. 1978 Aug;10(4):191-4.

Reference Type BACKGROUND
PMID: 360957 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

METC-nr 06-010

Identifier Type: -

Identifier Source: org_study_id