Femoral and Epidural Block After Total Knee Arthroplasty

Chronic Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115945
• Other study ID #: SARI-01
• Status: Completed
• Phase: Phase 0
• First received: April 8, 2014
• Last updated: April 15, 2014
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of total knee arthroplasty

Exclusion Criteria:

• Patients with pain syndromes

• Patients using routinely medications for pain

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Other:
• DN4 test
The DN4 test was used to evaluate neuropathic pain.
• The SF 12 test
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
• HAD scale
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
• Visual analogue score
Visual analogue score vas used to evaluate pain.

Procedure:
• femoral block

• epidural block

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life was evaluated with SF 12 test.		3 months	Yes
Other	Neuropathic pain was evaluated with DN4 test.		3 months.	Yes
Primary	Persistent surgical pain after total knee arthroplasty assessed by VAS scale		3 months	Yes
Secondary	The anxiety and depression was evaluated with Hospital anxiety and depression scale.		3 months	Yes