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Femoral and Epidural Block After Total Knee Arthroplasty

Primary Purpose

Acute Postoperative Pain, Chronic Postoperative Pain

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
DN4 test
The SF 12 test
HAD scale
Visual analogue score
femoral block
epidural block
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Postoperative Pain focused on measuring chronic postoperative pain, total knee arthroplasty, femoral block, We aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of total knee arthroplasty

Exclusion Criteria:

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

Sites / Locations

  • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

epidural block

femoral block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Persistent surgical pain after total knee arthroplasty assessed by VAS scale

Secondary Outcome Measures

The anxiety and depression was evaluated with Hospital anxiety and depression scale.

Full Information

First Posted
April 8, 2014
Last Updated
April 15, 2014
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT02115945
Brief Title
Femoral and Epidural Block After Total Knee Arthroplasty
Official Title
COMPARISON OF CONTINUOUS FEMORAL NERVE BLOCK AND PATIENT CONTROLLED EPIDURAL ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain, Chronic Postoperative Pain
Keywords
chronic postoperative pain, total knee arthroplasty, femoral block, We aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epidural block
Arm Type
Experimental
Arm Description
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.
Arm Title
femoral block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DN4 test
Intervention Description
The DN4 test was used to evaluate neuropathic pain.
Intervention Type
Other
Intervention Name(s)
The SF 12 test
Other Intervention Name(s)
SHORT FORM 12
Intervention Description
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
Intervention Type
Other
Intervention Name(s)
HAD scale
Other Intervention Name(s)
The anxiety/depression scale
Intervention Description
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
Intervention Type
Other
Intervention Name(s)
Visual analogue score
Other Intervention Name(s)
VAS score
Intervention Description
Visual analogue score vas used to evaluate pain.
Intervention Type
Procedure
Intervention Name(s)
femoral block
Intervention Type
Procedure
Intervention Name(s)
epidural block
Primary Outcome Measure Information:
Title
Persistent surgical pain after total knee arthroplasty assessed by VAS scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Quality of life was evaluated with SF 12 test.
Time Frame
3 months
Title
Neuropathic pain was evaluated with DN4 test.
Time Frame
3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of total knee arthroplasty Exclusion Criteria: Patients with pain syndromes Patients using routinely medications for pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Sari, Assistant Prof
Organizational Affiliation
Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatma Şengül, MD
Organizational Affiliation
Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FabrizioGalimberti Galimberti, Medical Student
Organizational Affiliation
Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bilge Karslı, Prof
Organizational Affiliation
Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, Associate Prof
Organizational Affiliation
Department of Outcomes Research, Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murat Bakıs, Assistant Prof
Organizational Affiliation
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
City
Aydın
ZIP/Postal Code
09100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23142441
Citation
Chan EY, Fransen M, Sathappan S, Chua NH, Chan YH, Chua N. Comparing the analgesia effects of single-injection and continuous femoral nerve blocks with patient controlled analgesia after total knee arthroplasty. J Arthroplasty. 2013 Apr;28(4):608-13. doi: 10.1016/j.arth.2012.06.039. Epub 2012 Nov 8.
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Femoral and Epidural Block After Total Knee Arthroplasty

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