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

Xueye Han, Tong Ren, Yang Wang, Nan Ji, Fang Luo, Xueye Han, Tong Ren, Yang Wang, Nan Ji, Fang Luo

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 < .001).

Conclusions: Infiltration of ropivacaine and Diprospan can achieve satisfactory postoperative pain relief after craniotomy; it is a simple, easy, and safe technique, worth clinical promotion.

Trial registration: ClinicalTrials.gov NCT00407306.

Conflict of interest statement

The authors declare no conflicts of interest.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Anesthesia Research Society.

Figures

Figure 1.
Figure 1.
CONSORT study diagram. CONSORT indicates Consolidated Standards of Reporting Trials.
Figure 2.
Figure 2.
Perioperative HR and MAP. Notes: Data were mean with 95% CI over the study period. There were no statistically significant differences in the perioperative HR and MAP. Diprospan group: ropivacaine plus diprospan group; Control group: ropivacaine alone group; t1: before anesthetic induction, t2: skin cutting, t3: skull drilling, t4:skin closure, t5: surgery ending. CI indicates confidence interval; HR, heart rate; MAP, mean arterial pressure.
Figure 3.
Figure 3.
The time of first PCA demand. Kaplan-Meier estimates the time of first PCA demand among patients who were given diprospan as an adjuvant (diprospan group) or ropivacaine alone (control group) for pre-emptive incision site infiltration. CI indicates confidence interval; HR, hazard ratio; PCA, patient-controlled analgesia.

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