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临床试验/NCT07008443
NCT07008443已完成4 期

An Integrated Artificial Intelligence Approach for Predicting Analgesic Time Based on Nalbuphine Versus Morphine as Adjuvants to Bupivacaine in Ultrasound-Guided Supraclavicular Block

Alzahraa Ahmed Abbas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Analgesic Duration

研究概览

简要总结

This study investigated the effect of adding nalbuphine or morphine to bupivacaine for supraclavicular brachial plexus block in upper limb surgeries. Sixty adult patients were randomized into three groups: control (bupivacaine + saline), nalbuphine, and morphine. The primary objective was to compare the duration of analgesia between the groups. A secondary goal was to assess whether artificial intelligence (AI), specifically the k-nearest neighbor (KNN) algorithm, could predict analgesic duration based on patient clinical and demographic data. The study concluded that both nalbuphine and morphine significantly prolonged analgesic duration and that the AI model showed high predictive accuracy.

详细描述

This prospective, randomized, double-blind clinical trial was conducted at Al-Zahraa and Damietta University Hospitals to evaluate the effectiveness of nalbuphine and morphine as adjuvants to bupivacaine in ultrasound-guided supraclavicular brachial plexus block. Sixty ASA I-II adult patients scheduled for upper limb surgeries were enrolled and divided equally into three groups. Group C received 0.5% bupivacaine with saline; Group N received bupivacaine with nalbuphine (50 μg/kg); Group M received bupivacaine with morphine (50 μg/kg). The primary outcome was analgesic duration, measured from block performance until the first request for postoperative analgesia. Secondary outcomes included onset and duration of sensory and motor block, total postoperative analgesic consumption, pain scores, and complications.

In parallel, a machine learning model using the K-Nearest Neighbor (KNN) algorithm was developed to predict analgesic duration from demographic and hemodynamic parameters. Exploratory data analysis and clustering methods confirmed the complex relationship between variables. The KNN model demonstrated high predictive accuracy (correlation coefficient ~0.95). The study concluded that both adjuvants extended analgesic duration and that AI models can assist in personalizing analgesic strategies based on patient profiles.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Randomization and drug preparation were concealed in sealed envelopes. Blinding was maintained for participants, providers, and data analysts.

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 21-60 years
  • ASA physical status I or II
  • Scheduled for elective upper limb surgery below the elbow
  • Provided written

排除标准

  • 未提供

研究组 & 干预措施

Control Group (Bupivacaine + Saline)

Active Comparator

Participants received 25 ml of 0.5% bupivacaine plus 5 ml of normal saline via ultrasound-guided supraclavicular brachial plexus block.

干预措施: Bupivacaine + saline (Drug)

Nalbuphine Group (Bupivacaine + Nalbuphine)

Experimental

Participants received 25 ml of 0.5% bupivacaine plus nalbuphine at 50 µg/kg via ultrasound-guided supraclavicular brachial plexus block

干预措施: Bupivacaine + nalbuphine (Drug)

Morphine Group (Bupivacaine + Morphine)

Experimental

Participants received 25 ml of 0.5% bupivacaine plus morphine at 50 µg/kg via ultrasound-guided supraclavicular brachial plexus block.

干预措施: Bupivacaine + morphine (Drug)

结局指标

主要结局

Analgesic Duration

时间窗: From block administration to first request for postoperative analgesia (up to 24 hours)

Duration of analgesia measured in hours from the time of performing the supraclavicular brachial plexus block until the patient's first request for postoperative pain relief.

次要结局

  • Total Postoperative Analgesic Consumption(Within 24 hours postoperatively)

研究者

发起方
Alzahraa Ahmed Abbas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alzahraa Ahmed Abbas

Assistant Lecturer of Anesthesia, Damietta Faculty of Medicine, Al-Azhar University

Al-Azhar University

研究点 (1)

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