Femoral and Epidural Block After Total Knee Arthroplasty

Early Phase 1

Completed

• Conditions: Acute Postoperative Pain; Chronic Postoperative Pain
• Interventions: Other: DN4 test; Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score; Procedure: femoral block; Procedure: epidural block

• Registration Number: NCT02115945
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-15
• Last Update Submitted: 2014-04-15
• Study First Posted: 2014-04-16
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of total knee arthroplasty

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epidural block	DN4 test	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.
epidural block	The SF 12 test	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.
epidural block	HAD scale	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.
femoral block	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.
epidural block	Visual analogue score	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.
epidural block	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.
femoral block	DN4 test	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.
femoral block	The SF 12 test	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.
femoral block	HAD scale	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.
femoral block	Visual analogue score	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.

Primary Outcome Measures

Name	Time	Method
Persistent surgical pain after total knee arthroplasty assessed by VAS scale	3 months

Secondary Outcome Measures

Name	Time	Method
The anxiety and depression was evaluated with Hospital anxiety and depression scale.	3 months

Trial Locations

Locations (1)

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department; 🇹🇷 Aydın, Turkey