Femoral and Epidural Block After Total Knee Arthroplasty

April 15, 2014 updated by: SINEM SARI, Aydin Adnan Menderes University

COMPARISON OF CONTINUOUS FEMORAL NERVE BLOCK AND PATIENT CONTROLLED EPIDURAL ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY

Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and aim Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

Methods The study was of randomized, prospective, and double-blind design and was conducted with 80 patients who had undergone total knee prosthetic replacement surgery with the insertion of a femoral nerve block or epidural block catheter to initiate postoperative analgesia. One-sided spinal anesthesia was performed in all the patients. Postoperative pain control was achieved with the administration via catheter using bupivacaine for patient-controlled analgesia. Acute postoperative pain was evaluated in the first 24 hours and chronic postoperative pain in the 1st and 3rd months following surgery. The anxiety/depression scale was used to assess anxiety and depression, the SF 12 test was used to evaluate quality of life, and the DN4 test was employed at patient visits at the 1st and 3rd months.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

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

  • Turkey
      • Aydın, Turkey, 09100
        • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of total knee arthroplasty

Exclusion Criteria:

  • Patients with pain syndromes
  • Patients using routinely medications for pain

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: epidural block
Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain.
Other: HAD scale
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
Other Names:
  • The anxiety/depression scale
Other: The SF 12 test
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
Other Names:
  • SHORT FORM 12
Other: Visual analogue score
Visual analogue score vas used to evaluate pain.
Other Names:
  • VAS score
Other: DN4 test
The DN4 test was used to evaluate neuropathic pain.
Procedure: epidural block
Active Comparator: femoral block
Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain.
Other: HAD scale
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
Other Names:
  • The anxiety/depression scale
Other: The SF 12 test
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
Other Names:
  • SHORT FORM 12
Other: Visual analogue score
Visual analogue score vas used to evaluate pain.
Other Names:
  • VAS score
Other: DN4 test
The DN4 test was used to evaluate neuropathic pain.
Procedure: femoral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistent surgical pain after total knee arthroplasty assessed by VAS scale
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life was evaluated with SF 12 test.
Time Frame: 3 months
3 months
Neuropathic pain was evaluated with DN4 test.
Time Frame: 3 months.
3 months.

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Alparslan Turan, Associate Prof, Department of Outcomes Research, Cleveland Clinic
  • Study Chair: Sinem Sari, Assistant Prof, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
  • Principal Investigator: Fatma Şengül, MD, Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
  • Principal Investigator: FabrizioGalimberti Galimberti, Medical Student, Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
  • Principal Investigator: Bilge Karslı, Prof, Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
  • Principal Investigator: Murat Bakıs, Assistant Prof, Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey

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

February 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARI-01

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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