Abstract | BACKGROUND: STUDY DESIGN AND METHODS: This is a prospective, single-center, blinded, randomized, controlled trial included patients aged between 18 and 64 years, ASA physical status of I-II, scheduled for elective supratentorial tumor craniotomy under general anesthesia. We screened patients for enrollment from April 4, 2019 through August 15, 2019. The final study visit of the last patient was conducted on February 13, 2020. We randomly assigned eligible participants (1:1) to either the dexamethasone group who received incision-site infiltration of 0.5% ropivacaine plus 0.033% dexamethasone (N=70) or the control group who received 0.5% ropivacaine alone (N=70). Primary outcome was the cumulative sufentanil consumption (μg) within 48 hours postoperatively. Primary analysis was performed based on the modified intention-to-treat (MITT) principle. RESULTS: Baseline characteristics were similar between the groups (p>0.05). Sufentanil consumption during the first 48 hours postoperatively was 29.0 (10.7) μg in the dexamethasone group and 38.3 (13.7) μg in the control group (mean difference -9.3, 95% CI -13.4 to -5.1; p<0.001). There was no serious adverse effect directly associated with incision-site infiltration or local dexamethasone use. CONCLUSION: TRIAL REGISTRATION: ClinicalTrials.Gov (NCT03618264).
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Authors | Chunmei Zhao, Shaoheng Wang, Yuesong Pan, Nan Ji, Fang Luo |
Journal | Journal of pain research
(J Pain Res)
Vol. 14
Pg. 1071-1082
( 2021)
ISSN: 1178-7090 [Print] New Zealand |
PMID | 33907455
(Publication Type: Journal Article)
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Copyright | © 2021 Zhao et al. |