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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03414593

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Preemptive Peripheral Nerve Block Acute Pain	Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preoperative blocked leg: group preB 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 Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
Active Comparator: postoperative blocked leg: group postB 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 Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml

Arm

Intervention/Treatment

Experimental: preoperative blocked leg: group preB

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

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

Active Comparator: postoperative blocked leg: group postB

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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