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OpenTrials
Completed

NCT Number: NCT02115945

Femoral and Epidural Block 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.

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Key information

Conditions

Acute Postoperative Pain Chronic Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of total knee arthroplasty

Exclusion criteria

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

Treatment and study plan

DN4 test

Other

The DN4 test was used to evaluate neuropathic pain.

The SF 12 test

Other

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

Other names: SHORT FORM 12

HAD Scale

Other

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

Other names: The anxiety/depression scale

Visual analogue score

Other

Visual analogue score vas used to evaluate pain.

Other names: VAS score

femoral block

Procedure

Epidural block

Procedure

Primary outcomes

  1. Persistent surgical pain after total knee arthroplasty assessed by VAS scale

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

Other outcomes

  1. Quality of life was evaluated with SF 12 test.

    Time frame: 3 months

  2. Neuropathic pain was evaluated with DN4 test.

    Time frame: 3 months.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2014
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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