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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041190102

Registered date:24/12/2019

Cocktail analgesics during spinal surgery

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedscoliosis
Date of first enrollment27/01/2020
Target sample size46
Countries of recruitment
Study typeInterventional
Intervention(s)Group A: control group A total 40ml of saline is injected into the paraspinal muscle at the time of closure. Group B: cocktali group A total 40ml of cocktail analgesics, which 0.75% ropivacaine 20 ml, methylprednisolone 40 mg, ketoprofen 50 mg, and saline are mixed, is injected into the paraspinal muscles at the time of closure.

Outcome(s)

Primary OutcomePain score of postoperative pain (Numerical rating scale [NRS] 0 to 10 points)
Secondary Outcome1. Rescue usage (total epidural usage, transvenous analgesia usage and rescue frequency, total acetaminophen usage frequency and usage) 2. Adverse event

Key inclusion & exclusion criteria

Age minimum>= 12age old
Age maximum<= 25age old
GenderBoth
Include criteria1. Patients with scoliosis surgery and age of 12 years to 25 years old 2. Informed consent obtained for patients
Exclude criteria1. Patients with a history of local anesthetic allergy (such as xylocaine) 2. Patients with severe preoperative paralysis (manual muscle strength test 3 or less) 3. Patients with peptic ulcer 4. Patients with severe blood abnormalities 5. Patients with aspirin asthma 6. Patients with severe liver dysfunction 7. Patients with severe renal dysfunction 8. Patients with severe cardiac dysfunction 9. Patients with difficult pain assessment (such as intellectual disabilities) 10. Women who are pregnant or may be pregnant 11. Breastfeeding woman 12. Patinets who are judged to be inappropriate for research participation by the principal investigator

Related Information

Contact

Public contact
Name Koichiro Ide
Address 1-20-1,Handayama,Higashiku ,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2299
E-mail 1de.5one60@gmail.com
Affiliation Hamamatsu University Hospital
Scientific contact
Name Go Yoshida
Address 1-20-1,Handayama,Higashiku ,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2299
E-mail goy@hama-med.ac.jp
Affiliation Hamamatsu University Hospital