Efficacy of Peripheral Nerve Blocks in Rizarthrosis Ambulatory Surgery

Ambulatory Rizarthrosis Surgery Clinical Trial

Official title:

Added Blocking Effectiveness of the Radial and Median Nerves With Levobupivacaine in Postoperative Pain Control in Rizarthrosis Ambulatory Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01597479
• Other study ID #: IIBSP-LEV-2011-21
• Status: Recruiting
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: August 7, 2013
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Mireia R Rodríguez, anesthesiologist
• Phone: +34 5537541
• Email: mrodriguezpr[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determinate if peripherical block of radial and median nerves at the elbow guided by ultrasound, and using local anesthetic with a long-term and low concentration, are effective in the treatment of postoperative severe pain due to a selective sensory block at the surgical site.

Description:

This study is a prospective randomized clinical trial, including patients undergoing outpatient rizarthrosis surgery. The 50 patients will be randomized into 2 groups:

A. Group H (n = 25): Usual procedure is performed (axillary block under ultrasound guidance with the aid of a neurostimulator) using a local anesthetic with a short-term action (2-3 hours): mepivacaine 1%.

B. Group R (n = 25): Usual procedure + additional intervention: Axillary block (mepivacaine 1%) and peripherical radial and median nerves block at the elbow (levobupivacaine 0.125%, 5ml/nerve),also under ultrasound guidance with the help of a neurostimulator.

Postoperative analgesia is the same for the 2 groups of patients: fixed pattern of dexketoprofen and rescue pattern of Tramadol.

The primary endpoint is analyse postoperative pain at 24 and 48 hours of surgery in the 2 study groups, as measured by visual analog scale pain numeric (VAS24 -48) and the maximum VAS.

Data collection will be done by a nurse of the outpatient surgery area by a phone call at 24 and 48 hours postsurgery.

Other variables that we collected are:

• VAS at the time of the call.

• Maximum VAS.

• Time of onset of pain after hospital discharge.

• Need for rescue analgesia, and total dose used.

• Presence of nausea or vomiting, and medication used to control them.

• Presence of motor block and time reversal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women over 18 years.

• Ambulatory Surgery rizarthrosis.

• Acceptance free to participate in the study, with informed consent signed by patient, guardian or family member.

Exclusion Criteria:

• Patients < 18 years.

• The patient does not agree to participate in the study.

• Allergy to local anesthetics/NSAIDs

• Chronic pain treatment.

• neurological diseases.

• CI locoregional anesthesia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ambulatory Rizarthrosis Surgery

Intervention

Drug:
• Levobupivacaine
In group R, we practice a peripheral blockade on radial and median nerves using a local anesthetic and long-term low concentration: 0.125% levobupivacaine, 5 ml per nerve, a total dose of 6.25 mg. These blocks are guided by ultrasound and neurostimulator.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of peripherical nerve blockade	The primary endpoint will assess pain measured by visual analogue scale numerical pain (VAS). Determine the maximum VAS and the VAS at 24 and 48 hours postoperatively. The analysis of this variable at the end of the study will confirm or not the effectiveness of proposed therapeutic strategy.	2 years	No