Status:
UNKNOWN
Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hou...
Eligibility Criteria
Inclusion
- Patients scheduled for elective craniotomy under general anesthesia;
- Age 18-64 years;
- American Society of Anesthesiologists (ASA) physical status of I or II;
- Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
- Patients required to fix their head in a head clamp during the operation.
Exclusion
- Previous history of craniotomy;
- Plan to delay extubation or no plan to extubate;
- Patients who cannot use the patient-controlled analgesia (PCA) device;
- Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
- Body mass index (BMI) \<15 or \>35;
- Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
- History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
- History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
- Pregnant or at breastfeeding;
- Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
- Glasgow Coma Scale \<15 before the surgery;
- Intracranial hypertension;
- Peri-incisional infection;
- Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04488315
Start Date
October 1 2022
End Date
December 25 2023
Last Update
November 21 2023
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070