Femoral and Epidural Block After Total Knee Arthroplasty

NCT ID: NCT02115945

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Acute Postoperative Pain Chronic Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

DN4 test

Intervention Type OTHER

The DN4 test was used to evaluate neuropathic pain.

The SF 12 test

Intervention Type OTHER

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

HAD scale

Intervention Type OTHER

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Visual analogue score

Intervention Type OTHER

Visual analogue score vas used to evaluate pain.

epidural block

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

DN4 test

Intervention Type OTHER

The DN4 test was used to evaluate neuropathic pain.

The SF 12 test

Intervention Type OTHER

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

HAD scale

Intervention Type OTHER

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Visual analogue score

Intervention Type OTHER

Visual analogue score vas used to evaluate pain.

femoral block

Intervention Type PROCEDURE

Interventions

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DN4 test

The DN4 test was used to evaluate neuropathic pain.

Intervention Type OTHER

The SF 12 test

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Intervention Type OTHER

HAD scale

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Intervention Type OTHER

Visual analogue score

Visual analogue score vas used to evaluate pain.

Intervention Type OTHER

femoral block

Intervention Type PROCEDURE

epidural block

Intervention Type PROCEDURE

Other Intervention Names

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SHORT FORM 12 The anxiety/depression scale VAS score

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of total knee arthroplasty

Exclusion Criteria

* Patients with pain syndromes
* Patients using routinely medications for pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SINEM SARI

MD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinem Sari, Assistant Prof

Role: STUDY_CHAIR

Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department

Fatma Şengül, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey

FabrizioGalimberti Galimberti, Medical Student

Role: PRINCIPAL_INVESTIGATOR

Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio

Bilge Karslı, Prof

Role: PRINCIPAL_INVESTIGATOR

Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey

Alparslan Turan, Associate Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Outcomes Research, Cleveland Clinic

Murat Bakıs, Assistant Prof

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey

Locations

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Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23142441 (View on PubMed)

Other Identifiers

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SARI-01

Identifier Type: -

Identifier Source: org_study_id

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