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Clinical Trials/NCT03414593
NCT03414593
Unknown
Not Applicable

Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

Asan Medical Center1 site in 1 country20 target enrollmentJanuary 2, 2018

Overview

Phase
Not Applicable
Intervention
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
Conditions
Pain, Postoperative
Sponsor
Asan Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Analgesic duration of nerve block
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hyuk Lee

clinical assistant professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

preoperative blocked leg: group preB

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

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

postoperative blocked leg: group postB

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

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

Outcomes

Primary Outcomes

Analgesic duration of nerve block

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

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.

Secondary Outcomes

  • 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 Sites (1)

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