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

Not Applicable

• Conditions: Acute Pain; Preemptive Peripheral Nerve Block; Pain, Postoperative
• Interventions: Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine

• Registration Number: NCT03414593
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-02
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-26
• Last Update Submitted: 2018-01-26
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative blocked leg: group preB	Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine	ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision
postoperative blocked leg: group postB	Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine	ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision

Primary Outcome Measures

Name	Time	Method
Analgesic duration of 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	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

Name	Time	Method
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	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	at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1	any other sensation except pain

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of