NCT03414593

Brief Summary

The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus. After induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs. When the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 2, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

January 15, 2018

Last Update Submit

January 26, 2018

Conditions

Pain, PostoperativePreemptive Peripheral Nerve BlockAcute Pain

Keywords

preemptive analgic effectpopliteal sciatic nerve blockBilateral Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • Analgesic duration of nerve block

    The difference of NRS during study time between group preB and group postB The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.

    at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1

Secondary Outcomes (2)

  • Difference of analgesic consumption between both group

    at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1

  • side effect of popliteal sciatic nerve block

    at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1

Study Arms (2)

preoperative blocked leg: group preB

EXPERIMENTAL

ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision

Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine

postoperative blocked leg: group postB

ACTIVE COMPARATOR

ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision

Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine

Interventions

Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaineDRUG

Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml

postoperative blocked leg: group postBpreoperative blocked leg: group preB

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults between the ages of 20 and 80
  • bilateral hallux valgus surgery on the same day
  • ASA class 1 or 2
  • Patients who have voluntarily agreed in writing to participate in the trial

You may not qualify if:

  • Patient with side effects on local anesthetics or steroids
  • Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  • Patients with uncontrolled medical or psychiatric problem
  • Patient does not agree to participate in the study
  • Patients who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • JongHyuk Lee, md

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients who underwent surgery on both feet at the same time. One foot is performed before surgery and the other is performed after surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 30, 2018

Study Start

January 2, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

KR(1)