Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain (PAINLESS)

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Supratentorial Brain Tumor; Pain

Treatments: Drug: Ketorolac; Drug: Ropivacaine; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04380298

KY-2018-034-02-7

Details and patient eligibility

About

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 infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

The ketorolac group

Experimental group

Description:

Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.

Treatment:

Drug: Ketorolac

Drug: Epinephrine

Drug: Ropivacaine

The control group

Active Comparator group

Description:

In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.

Treatment:

Drug: Epinephrine

Drug: Ropivacaine