Clinical trial NCT02115945: Femoral and Epidural Block After Total Knee Arthroplasty
Official title: COMPARISON OF CONTINUOUS FEMORAL NERVE BLOCK AND PATIENT CONTROLLED EPIDURAL ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Postoperative Pain
Chronic Postoperative Pain
Keywords: chronic postoperative pain
total knee arthroplasty
femoral block
We aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of total knee arthroplasty

Exclusion Criteria:

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

Primary outcomes:
measure: Persistent surgical pain after total knee arthroplasty assessed by VAS scale
timeFrame: 3 months
Secondary outcomes:
measure: The anxiety and depression was evaluated with Hospital anxiety and depression scale.
timeFrame: 3 months
Other outcomes:
measure: Quality of life was evaluated with SF 12 test.
timeFrame: 3 months
measure: Neuropathic pain was evaluated with DN4 test.
timeFrame: 3 months.
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Study officials:
affiliation: Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
name: Sinem Sari, Assistant Prof
role: STUDY_CHAIR
affiliation: Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
name: Fatma Şengül, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
name: FabrizioGalimberti Galimberti, Medical Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
name: Bilge Karslı, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Outcomes Research, Cleveland Clinic
name: Alparslan Turan, Associate Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey
name: Murat Bakıs, Assistant Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.