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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02115945
Other study ID # SARI-01
Secondary ID
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


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
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