Femoral/Sciatic Block for Knee Surgery

December 23, 2016 updated by: University of Sao Paulo General Hospital

Continuous Femoral Nerve Blockade and Single Shot Sciatic Nerve Block Compared to Intrathecal Morphine for Total Knee Arthroplasty

Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia and postoperative bleeding from intrathecal morphine with the continuous femoral and a single-shot sciatic nerve blockades.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare intrathecal morphine as a technique for analgesia with the femoral nerve blockade associated with a single-shot sciatic nerve blockade. Analgesic efficacy, the incidence of adverse effects, and postoperative bleeding were evaluated

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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:

  • Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty

Exclusion Criteria:

  • Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form

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 blockade
femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve
Procedure: femoral nerve blockade
femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery
Active Comparator: Morphine
intrathecal morphine
Procedure: morphine
Intrathecal morphine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Efficacy
Time Frame: baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours
Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).
baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Bleeding
Time Frame: baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours
Postoperative bleeding volume (ml)
baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Alfredo J Mansur, MD. PhD, Comissão de Ética para Análise de Projetos de Pesquisa-CAPPesq - HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 26, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0257/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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