Efficacy of Peripheral Nerve Blocks in Rizarthrosis Ambulatory Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01597479
First received: May 7, 2012
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Ambulatory Rizarthrosis Surgery
Drug: Levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Added Blocking Effectiveness of the Radial and Median Nerves With Levobupivacaine in Postoperative Pain Control in Rizarthrosis Ambulatory Surgery

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Effectiveness of peripherical nerve blockade [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levobupivacaine
In the other group (R), we practice the peripherical nerves blockade guided by ultrasound and neurostimulator.
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.
No Intervention: No intervention
In one group (H) any intervention is practiced.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597479

Contacts
Contact: Mireia R Rodríguez, anesthesiologist +34 5537541 mrodriguezpr@santpau.cat
Contact: Rolf Hoffman, anaesthesiologist +34 5537541 ext H RHoffman@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Mireia Rodriguez, MD    + 34 93 553 75 41    mrodriguezpr@santpau.cat   
Contact: Rolf H Hoffman, MD    + 34 93 553 75 41    rhoffman@santpau.cat   
Principal Investigator: Mireia R Rodríguez, anesthesiologist         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Mireia Rodriguez, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01597479     History of Changes
Other Study ID Numbers: IIBSP-LEV-2011-21
Study First Received: May 7, 2012
Last Updated: August 7, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014