Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy

Capital Medical University

Status: Enrolling

Conditions: Post-craniotomy; Pain

Treatments: Drug: Ropivacaine; Drug: FA+Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07209345

KY-2018-034-02-11

Details and patient eligibility

About

Post-craniotomy pain is common and often associated with poor outcomes. Flurbiprofen axetil (FA) is an injectable NSAID for postoperative analgesia, however, the impact of local FA, remains elusive on post-craniotomy 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. On base of the previous report that local NSAIDs achieved therapeutic tissue concentrations despite a plasma concentration of <5% of that of systemic administration, a low-dose of FA might be considered a preferential option for local infiltration to avoid anti-platelet related side effects, such as intra-cerebral bleeding. In this study, the investigators attempt to evaluate the clinical effects of pre-emptive scalp infiltration with low-dose FA and ropivacaine for postoperative analgesia after craniotomy.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-64 years;
2. ASA physical status of I - II;
3. Scheduled for craniotomy under general anesthesia;
4. 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. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;
5. History of allergy to any drug used in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups

Ropivacaine group

Active Comparator group

Description:

0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision

Treatment:

Drug: Ropivacaine

FA+Ropivacaine group

Experimental group

Description:

5mg FA and 0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision

Treatment:

Drug: FA+Ropivacaine