Status:
UNKNOWN
Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Pain
Supratentorial Brain Tumor
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical pilot study to compare the efficacy and safety of pre-emptive scalp infiltratio...
Eligibility Criteria
Inclusion
- Scheduled for elective supratentorial tumour resection;
- Planned general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status I - II;
- Age ranging from 18 to 65 years old;
- Participates required to fix their head in a head clamp intraoperatively;
- Participates with an anticipated awake within 2 hours after surgery.
Exclusion
- Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
- Expected delayed extubation or no plan to extubate;
- History of neurosurgeries;
- Long-term use of analgesics and sedatives (more than 2 weeks)
- Receiving any painkiller within 24 h before the operation;
- Extreme body mass index (BMI) (less than 15 or more than 35);
- Patients with impaired cardiopulmonary;
- Patients with impaired renal function;
- Patients with impaired hepatic function;
- History of chronic headache;
- Patients with cognitive deficit;
- Patients with intellectual disability;
- Patients with uncontrolled epilepsy;
- Patients with psychiatric disorders;
- Difficulties in using PCA device
- Difficulties in understanding the use of numeral rating scale (NRS) ;
- Patients with suspected intracranial hypertension;
- Pregnant or at breastfeeding;
- Infection at the incisional site;
- History of radiation therapy and chemotherapy preoperatively
- With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04380298
Start Date
December 1 2020
End Date
August 31 2021
Last Update
September 9 2020
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