Overview

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 siteļ¼›

- History of radiation therapy and chemotherapy preoperatively

- With great likelihood of postoperative radiation therapy and chemotherapy based on
preoperative imaging.