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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03414593
• Other study ID #: 2017-0856
• Status: Active, not recruiting
• Phase: N/A
• First received: January 15, 2018
• Last updated: January 26, 2018
• Start date: January 2, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Hallux Valgus
• Pain, Postoperative
• Preemptive Peripheral Nerve Block

Intervention

Drug:
• Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
Secondary	side effect of popliteal sciatic nerve block	any other sensation except pain	at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1