Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Epinephrine; Epinephryl borate; Ketorolac; Ketorolac Tromethamine; Racepinephrine; Ropivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.