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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Supratentorial Brain Tumor; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04141319

KY-2018-034-02-6

Details and patient eligibility

About

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.

Full description

The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.

Enrollment: 100 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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100 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 scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.

Treatment:

Drug: Epinephrine

Drug: Ropivacaine