Trials | |
Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial | |
Study Protocol | |
Fang Luo1  Chunmei Zhao1  Wei Zhang2  Chunzhao Li3  Nan Ji3  | |
[1] Department of Day Surgery and Pain Management, Beijing Tiantan Hospital, Capital Medical University, 100070, Beijing, People’s Republic of China;Department of Day Surgery, Beijing Tiantan Hospital, Capital Medical University, 100070, Beijing, People’s Republic of China;Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, 100070, Beijing, People’s Republic of China; | |
关键词: Dexamethasone palmitate emulsion; Ropivacaine; Craniotomy; Pre-incisional infiltration; Postoperative pain; | |
DOI : 10.1186/s13063-022-06936-z | |
received in 2022-08-04, accepted in 2022-11-15, 发布年份 2022 | |
来源: Springer | |
【 摘 要 】
BackgroundPost-craniotomy pain is a common occurrence which is associated with poor outcomes. Pre-emptive scalp infiltration with dexamethasone and ropivacaine has been proven effective in previous studies but with limited clinical significance. Dexamethasone palmitate emulsion (D-PAL) is a pro-drug incorporating dexamethasone into lipid microspheres with greater anti-inflammatory activity and fewer side effects than free dexamethasone. However, its effects in post-craniotomy pain management remain unknown. This study hypothesizes that pre-emptive scalp infiltration with ropivacaine plus D-PAL emulsion can achieve superior analgesic effects to ropivacaine alone in adult patients undergoing craniotomy.Methods/designThis is a single center, randomized controlled trial enrolling 130 patients scheduled for supratentorial craniotomy, which is expected to last longer than 4 h. We compare the efficacy and safety for postoperative pain relief of ropivacaine plus D-PAL group and ropivacaine alone group following pre-emptive scalp infiltration. Primary outcome will be pain Numerical Rating Scale at 24 h postoperatively. Secondary outcomes will include further analgesia evaluations and drug-related complications within a follow-up period of 3 months.DiscussionThis is the first randomized controlled trial aiming to assess the possible benefits or disadvantages of D-PAL emulsion for incisional pain in craniotomy. It may provide an alternative to optimize pain outcome for neurosurgical patients.Trial registrationClinicalTrials.gov (NCT04488315). Registered on 19 July 2020.
【 授权许可】
CC BY
© The Author(s) 2022
【 预 览 】
Files | Size | Format | View |
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RO202305064218713ZK.pdf | 1245KB | download | |
Fig. 2 | 1694KB | Image | download |
MediaObjects/12902_2022_1215_MOESM10_ESM.docx | 12KB | Other | download |
Fig. 2 | 361KB | Image | download |
【 图 表 】
Fig. 2
Fig. 2
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