Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

Beijing Tiantan Hospital216 enrolled

Overview

Post-craniotomy pain remains a major challenge in patient care following neurosurgery.Flurbiprofen axetil (FA), as an injectable nonselective cyclooxygenase inhibitor, is a widely prescribed NSAID for postoperative pain. As FA is highly lipophilic by merging into emulsified lipid microspheres, it has a high affinity to the surgical incision and inflammatory tissues to achieve targeted drug therapy and prolonged duration of action, thus providing a basis for its local use to achieve efficacy and safety comparable to or greater than systemic administration. In this study, we attempt to evaluate the clinical effects of FA as an adjunct to ropivacaine in pre-emptive scalp infiltration to prevent or reduce pain after craniotomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

216

Conditions

Postoperative Pain

Interventions

Th group will receive 0.17% FA and 0.5% ropivacaine for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.

ropivacaine aloneDRUG

The ropivacaine alone group will receive 0.5% ropivacaine alone for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age minimum 18 years; 2. ASA physical status of I - II; 3. Body mass index (BMI) of 15 - 30; 4. Scheduled for supratentorial craniotomy under general anesthesia; 5. Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy. Exclusion Criteria: 1. Glasgow Coma Scale \<15; 2. Unable to use the PCIA device or comprehend the pain NRS; 3. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery; 4. History of craniotomy or scalp infection; 5. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease; 6. History of allergy to any drug used in the study; 7. Pregnancy and breastfeeding.

Outcomes

Primary Outcomes

Total consumption of sufentanil with PCIA device at 48 hours postoperatively.

A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.

Time frame: at 48 hours postoperatively

Secondary Outcomes

Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy

Time frame: at 24 hours postoperatively

Time to first PCIA button press after craniotomy

Time frame: after craniotomy

Pain NRS scores at 2 hours after craniotomy