Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial

Abstract

BACKGROUND: Preemptive injection of local anesthetics can prevent postoperative pain at the incision site, but the analgesic effect is insufficient and is maintained only for a relatively short period of time. Diprospan is a combination of quick-acting betamethasone sodium phosphate and long-acting betamethasone dipropionate. Whether Diprospan as an adjuvant to local anesthetic can achieve postcraniotomy pain relief has not been studied yet. METHODS: This is a prospective, single-center, blinded, randomized, controlled clinical study, which included patients ages 18 and 64 years, with American Society of Anaesthesiologists (ASA) physical statuses of I to III, scheduled for elective supratentorial craniotomy. We screened patients for enrollment from September 3, 2019, to August 15, 2020. The final follow-up was completed on February 15, 2021. Eligible patients were randomly assigned to either the Diprospan group, who received incision-site infiltration of 0.5% ropivacaine plus Diprospan (n = 48), or the control group, who received 0.5% ropivacaine alone (n = 48), with a distribution ratio of 1:1. Primary outcome was the cumulative sufentanil (μg) consumption through patient-controlled analgesia (PCA) within 48 hours after surgery. Primary analysis was performed based on the intention-to-treat (ITT) principle. RESULTS: Baseline characteristics were not significantly different between the 2 groups (P >.05). In the Diprospan group, the cumulative sufentanil consumption through PCA was 5 (0-16) µg within 48 hours postoperatively, which was significantly lower than that in the control group (38 [30.5-46] µg; P