Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?

February 4, 2015 updated by: Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa

Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial

Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Portugal
      • Penafiel, Portugal, 4564-007
        • Centro Hospitalar Tâmega e Sousa

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:

  • Elective total knee arthroplasty

Exclusion Criteria:

  • Coagulopathy
  • Neuropathy
  • Morbid obesity
  • local anesthetics allergy

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-shot nerve block
Efficacy compared to epidural
Drug: Ropivacaine perineural injection
Ultrasound guided single-shot femoral nerve block
Active Comparator: Continuous epidural
Continuous epidural perfusion
Drug: morphine and ropivacaine
Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on the numeric pain score
Time Frame: 48 hours
Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects as a measure of safety and tolerability
Time Frame: 48 hours
Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.
48 hours
Rescue analgesic consumption.
Time Frame: 48 hours
Opioid rescue needs in the first 48 hours after surgery.
48 hours
Patients satisfaction.
Time Frame: 48 hours
Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).
48 hours

Collaborators and Investigators

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

Sponsor

Centro Hospitalar do Tâmega e Sousa

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

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTSA001

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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