RE-duce 试验：神经周围给予地塞米松对缓解开颅术后疼痛的头皮神经阻滞的影响——一项随机对照试验的研究方案。

REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain-a study protocol for a randomized controlled trial.

机构信息

Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.

Department of Day Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

出版信息

Trials. 2021 Nov 4;22(1):772. doi: 10.1186/s13063-021-05747-y.

DOI:10.1186/s13063-021-05747-y

PMID:34736497

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8567555/

Abstract

BACKGROUND

Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however, transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly for at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the background of perioperative glucocorticoid deserves further clarification.

METHODS

The REDUCE trial is a prospective, single-center, parallel-group randomized controlled trial involving a total of 156 adults scheduled for elective craniotomy with general anesthesia. Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. The primary outcome will be the duration of analgesia, defined as the time between the performance of the block and the first analgesic request.

DISCUSSION

The REDUCE trial aims to further assess the analgesic effect of single dexamethasone as an adjuvant to scalp nerve blocks for relief of postcraniotomy pain without the background of perioperative glucocorticoid.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04648358 . Registered on November 30, 2020.

摘要

背景

在颅脑手术后的头 2 天，疼痛很常见。镇痛不足可能会增加术后并发症的风险。大多数颅脑手术后的疼痛源自颅顶肌肉和头皮软组织。头皮神经阻滞加局部麻醉似乎可以提供有效、安全但短暂的术后镇痛，但似乎无法满足颅脑手术的要求。目前，外周地塞米松已被观察到可显著延长神经阻滞（如隐静脉神经阻滞、收肌管阻滞、胸椎旁神经阻滞、臂丛神经阻滞）的镇痛时间。相反，一项研究报道，神经周围地塞米松似乎不会延长颅脑手术后的镇痛时间。然而，该研究中的所有患者在围手术期均接受了至少 7 天的 24mg 口服或静脉地塞米松，这可能掩盖了局部低剂量神经周围地塞米松的作用。因此，在没有围手术期糖皮质激素背景的情况下，单次头皮神经阻滞中地塞米松的镇痛效果需要进一步阐明。

方法

RE-DUCE 试验是一项前瞻性、单中心、平行组随机对照试验，共纳入 156 例择期全身麻醉下接受颅脑手术的成年人。患者将随机分为两组：对照组（n=78）将接受 0.5%布比卡因加肾上腺素 1:200000 的生理盐水头皮神经阻滞；DEX 组（n=78）将接受 0.5%布比卡因加肾上腺素 1:200000 的 4mg 地塞米松头皮神经阻滞。主要结局是镇痛持续时间，定义为阻滞完成至首次镇痛要求的时间。