Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb

September 10, 2014 updated by: Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
    • Estado Nueva Esparta
      • Porlamar, Estado Nueva Esparta, Venezuela, 6301
        • Servicio de Anestesiologia Hospital "Dr. Luis Ortega"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia

Exclusion Criteria:

  • Patients with any anesthetic or surgical complication
  • Patients with neuromuscular diseases
  • Allergy to any of the drugs used in the study
  • Inability to understand and use a pain scale
  • Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: femoral block by US and NE and intravenous analgesia
preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia
Procedure: Femoral block by ultrasound and neurostimulation
Drug: Intravenous analgesia
Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia
Experimental: Intravenous analgesia
Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia
Drug: Intravenous analgesia
Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperatory EVA values and need for rescue analgesia with IV morphine
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central Dr. Luis Ortega

Investigators

  • Principal Investigator: Beatriz S Arismendi Gomez, MD, Hospital "Dr Luis Ortega"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 7, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Femoral Block

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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