Status:
COMPLETED
Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sym...
Eligibility Criteria
Inclusion
- Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status of I ,II or III;
- Participates with an anticipated fully recovery within 2 hours postoperatively;
Exclusion
- History of craniotomy;
- Expected delayed extubation or no plan to extubate;
- Participants who cannot use a patient-controlled analgesia (PCA) device;
- Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
- Extreme body mass index (BMI) (\< 15 or \> 35);
- Allergy to opioids, triamcinolone acetonide or ropivacaine;
- 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;
- History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
- Pregnant or at breastfeeding;
- Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
- Preoperative Glasgow Coma Scale\< 15;
- Suspicion of intracranial hypertension;
- Peri-incisional infection;
- Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Key Trial Info
Start Date :
October 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06069804
Start Date
October 7 2023
End Date
December 31 2023
Last Update
April 3 2024
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050