A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02235506
• Other study ID #: apsj0901
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: July 14, 2015
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Yeungnam University College of Medicine
• Contact: Sangjin Park, M.D.
• Phone: 82-53-620-3366
• Email: apsj0718[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.

Description:

The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Physical Status Classification I-II

• total knee arthroplasty

• 18-90 years

Exclusion Criteria:

• allergic to the local anesthetics

• cognitive impairment such as dementia

• coagulopathy

• motor and sensory impairment

• patient refusal

• BMI >39

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• epidural infusion
Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
• femoral sciatic
After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

Device:
• epidural infusion
Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
• femoral sciatic
After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of side effects	Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.	during 5 days after the end of operation	Yes
Secondary	Pain	Pain according to visual analogue scale at rest and on mobilization.	during 5 days after the end of operation	No
Secondary	Motor blockade at rest and on mobilization	Motor blockade is estimated using a modified Bromage scale	during 5 days after the end of operation	No