REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Capital Medical University

Status: Completed

Conditions: Postoperative Pain; Scalp Nerve Blocks; Craniotomy; Dexamethasone

Treatments: Drug: Dexamethasone combined with bupivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04648358

KY 2018-034-02-9

Details and patient eligibility

About

Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.

Enrollment: 156 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for elective supratentorial craniotomy under general anesthesia;
• age 18 to 64 years;
• an American Society of Anesthesiologists (ASA) physical status of I, II or III;
• preoperative Glasgow Coma Scale (GCS) score of 15/15.

Exclusion criteria

• History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy;
• Inability to understand or use the pain scales before surgery;
• Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery;
• Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery;
• Pregnancy or breastfeeding;
• Extreme body mass index (BMI) (< 15 or > 35);
• Participation in another interventional trial that interferes with the intervention or outcome of this trial;
• Refusal or inability of the patient and/or legal guardian to provide informed consent;
• Coagulopathy;
• Infection around the puncture point;
• History of allergies to any of the study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

156 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000

Treatment:

Drug: Bupivacaine

DEX4mg group

Experimental group

Description:

DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.

Treatment:

Drug: Dexamethasone combined with bupivacaine