Cocktail analgesics during spinal surgery

JRCT ID: jRCTs041190102

Registered date:24/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: scoliosis
• Date of first enrollment: 27/01/2020
• Target sample size: 46
• Study type: Interventional

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 Outcome: Pain score of postoperative pain (Numerical rating scale [NRS] 0 to 10 points)

Secondary Outcome

1. 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
• Gender: Both

Include criteria

1. Patients with scoliosis surgery and age of 12 years to 25 years old
2. Informed consent obtained for patients

Exclude criteria

1. 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

• Primary Sponsor: Yoshida Go