NCT02235506

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

September 1, 2014

Last Update Submit

July 14, 2015

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Pain

    during 5 days after the end of operation

  • Motor blockade at rest and on mobilization

    during 5 days after the end of operation

Study Arms (2)

epidural infusion

EXPERIMENTAL

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,

Procedure: epidural infusionDevice: epidural infusion

femoral sciatic

EXPERIMENTAL

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.

Procedure: femoral sciaticDevice: femoral sciatic

Interventions

epidural infusionPROCEDURE

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.

Also known as: continuous lumbar epidural block
epidural infusion
femoral sciaticPROCEDURE

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.

Also known as: femoral nerve block and sciatic nerve block
femoral sciatic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists Physical Status Classification I-II
  • total knee arthroplasty
  • years

You may not qualify if:

  • allergic to the local anesthetics
  • cognitive impairment such as dementia
  • coagulopathy
  • motor and sensory impairment
  • patient refusal
  • BMI \>39

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, 705-035, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sangjin Park, M.D.

    Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangjin Park, M.D.

CONTACT

82-53-620-3366apsj0718@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 10, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

KR(1)