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临床试验/NCT07344181
NCT07344181进行中(未招募)不适用

Efficacy of Liposomal Bupivacaine Scalp Nerve Block for Postoperative Pain Management After Supratentorial Craniotomy:a Randomized Controlled Trial

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2024年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
118
试验地点
1
主要终点
NRS pain scores

研究概览

简要总结

This is a prospective, randomized, controlled trial conducted at Beijing Tiantan Hospital to evaluate the efficacy and safety of liposomal bupivacaine for scalp nerve block in managing postoperative pain after elective supratentorial craniotomy.

A total of 118 eligible patients (aged 18-64, ASA I-III) will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will receive a scalp nerve block using liposomal bupivacaine. The control group will receive a scalp nerve block using standard 0.5% bupivacaine. All patients will undergo standardized general anesthesia.

The primary outcome is postoperative pain intensity, measured by the Numerical Rating Scale (NRS) at multiple time points: 2, 12, 24, 48, and 72 hours after surgery. Secondary outcomes include the Glasgow Coma Scale (GCS) score, patient satisfaction, cumulative opioid consumption, and the incidence of adverse events.

The study aims to determine if a single administration of liposomal bupivacaine provides superior and prolonged analgesia compared to conventional bupivacaine, potentially improving pain management and recovery for craniotomy patients. The study duration is from October 2024 to May 2027.

详细描述

  1. Background and Rationale:

Postoperative pain following supratentorial craniotomy is a significant clinical concern, often requiring opioid-based analgesia. However, opioid use in neurosurgical patients is limited by side effects such as sedation, respiratory depression, and nausea, which can obscure neurological assessment and delay recovery. Scalp nerve blocks (SNBs) with local anesthetics like bupivacaine are a well-established component of multimodal analgesia for craniotomy, targeting the primary sources of postoperative pain-the pericranial muscles and scalp tissues. While effective, conventional bupivacaine provides analgesia for only up to 6-8 hours, leaving patients with inadequate pain control during the critical 72-hour postoperative period.

Liposomal bupivacaine (LB) is an extended-release formulation designed to provide sustained analgesia for up to 72 hours. Its efficacy has been demonstrated in various surgical settings, but its application in neurosurgery, particularly for scalp nerve blocks, remains underexplored. This study aims to investigate whether a single preoperative scalp nerve block with liposomal bupivacaine can provide superior and prolonged analgesia compared to standard bupivacaine, thereby reducing opioid consumption and improving patient outcomes following craniotomy. 2. Objectives:

Primary Objective: To compare the efficacy of liposomal bupivacaine versus standard bupivacaine for scalp nerve blocks in controlling postoperative pain, as measured by the Numerical Rating Scale (NRS) at 2, 12, 24, 48, and 72 hours after surgery.

Secondary Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-64 years.
  • Scheduled for elective supratentorial craniotomy under general anesthesia.
  • ASA physical status I-III.
  • Preoperative GCS score of
  • Ability to provide informed consent.

排除标准

  • Chronic pain syndromes, opioid tolerance, or psychiatric disorders.
  • Coagulopathy or infection at the block site.
  • Allergy to local anesthetics.
  • BMI <15 or >35.

研究组 & 干预措施

intervention group

Experimental

Preoperative scalp nerve block with liposomal bupivacaine.

干预措施: Preoperative scalp nerve block (Procedure)

Control Group

Active Comparator

Preoperative scalp nerve block with 0.5% bupivacaine.

干预措施: Preoperative scalp nerve block (Procedure)

结局指标

主要结局

NRS pain scores

时间窗: 2, 12, 24, 48, and 72 hours postoperatively

NRS pain scores at 2, 12, 24, 48, and 72 hours postoperatively.

次要结局

  • Opioid consumption(2, 12, 24, 48, and 72 hours postoperatively.)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

Beijing Tiantan Hospital

Beijing Tiantan Hospital

研究点 (1)

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