Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial

Trials

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

【 图 表 】

Fig. 2

Fig. 2