Femoral and Epidural Block After Total Knee Arthroplasty

NCT02115945 | Completed Early Phase 1 DMC

• 1 other identifier: SARI-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• Persistent surgical pain after total knee arthroplasty assessed by VAS scale

  3 months

Secondary Outcomes (1)

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

  3 months

Other Outcomes (2)

• Quality of life was evaluated with SF 12 test.

  3 months

• Neuropathic pain was evaluated with DN4 test.

  3 months.

Study Arms (2)

epidural block

EXPERIMENTAL

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.

Other: DN4 test; Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score; Procedure: epidural block

femoral block

ACTIVE COMPARATOR

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.

Other: DN4 test; Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score; Procedure: femoral block

Interventions

DN4 test OTHER

The DN4 test was used to evaluate neuropathic pain.

epidural block; femoral block

The SF 12 test OTHER

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

Also known as: SHORT FORM 12

epidural block; femoral block

HAD scale OTHER

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

Also known as: The anxiety/depression scale

epidural block; femoral block

Visual analogue score OTHER

Visual analogue score vas used to evaluate pain.

Also known as: VAS score

epidural block; femoral block

femoral block PROCEDURE

femoral block

epidural block PROCEDURE

epidural block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of total knee arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

Location

Related 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: 10.1016/j.arth.2012.06.039. Epub 2012 Nov 8.

  PMID: 23142441 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sinem Sari, Assistant Prof

  Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department

  STUDY CHAIR

• Fatma Şengül, MD

  Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey

  PRINCIPAL INVESTIGATOR

• FabrizioGalimberti Galimberti, Medical Student

  Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio

  PRINCIPAL INVESTIGATOR

• Bilge Karslı, Prof

  Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey

  PRINCIPAL INVESTIGATOR

• Alparslan Turan, Associate Prof

  Department of Outcomes Research, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Murat Bakıs, Assistant Prof

  Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 16, 2014
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

TU (1)