Status:
COMPLETED
Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Postoperative Pain
Neurosurgery
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
Laminoplasty and laminectomy are useful surgical procedures for the management of various conditions pertaining the spinal cord such as myelopathy, radiculopathy, neoplasm, stenosis, disc herniation, ...
Eligibility Criteria
Inclusion
- Patients scheduled for laminoplasty or laminectomy under general anesthesia
- American Society of Anesthesiologists (ASA) classification I or II
- Age 18 to 64 years
Exclusion
- Patient refusal
- Inability to give written informed consent
- Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS)
- Previous history of spinal surgery
- Allergy to opioids, methylprednisolone or ropivacaine
- Peri-incisional infection
- History of stroke or a major neurological deficit
- Trauma, deformity
- Psychological problems
- Extreme body mass index (BMI) (\< 15 or \> 35)
- History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects
- Patients using systemic steroids
- Pregnant or breastfeeding;
- Preoperative Glasgow Coma Scale \< 15
- Participants who have received radiation therapy or chemotherapy preoperatively, or a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04493463
Start Date
July 31 2020
End Date
May 6 2021
Last Update
May 19 2021
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070