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Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

Primary Purpose

Pain, Postoperative, Preemptive Peripheral Nerve Block, Acute Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring preemptive analgic effect, popliteal sciatic nerve block, Bilateral Hallux Valgus

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

preoperative blocked leg: group preB

postoperative blocked leg: group postB

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference of analgesic consumption between both group
The difference of usage of rescue analgesics during study time between group preB and group postB after the operation
side effect of popliteal sciatic nerve block
any other sensation except pain

Full Information

First Posted
January 15, 2018
Last Updated
January 26, 2018
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03414593
Brief Title
Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Official Title
Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Preemptive Peripheral Nerve Block, Acute Pain
Keywords
preemptive analgic effect, popliteal sciatic nerve block, Bilateral Hallux Valgus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who underwent surgery on both feet at the same time. One foot is performed before surgery and the other is performed after surgery.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preoperative blocked leg: group preB
Arm Type
Experimental
Arm Description
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision
Arm Title
postoperative blocked leg: group postB
Arm Type
Active Comparator
Arm Description
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
Intervention Description
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
Primary Outcome Measure Information:
Title
Analgesic duration of nerve block
Description
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.
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
Secondary Outcome Measure Information:
Title
Difference of analgesic consumption between both group
Description
The difference of usage of rescue analgesics during study time between group preB and group postB after the operation
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
Title
side effect of popliteal sciatic nerve block
Description
any other sensation except pain
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongHyuk Lee, md
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

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Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

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