Skip to main content
OpenTrials
Completed

NCT Number: NCT07008443

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Zahraa University Hospital

Cairo, Alexandria Governorate, 21415, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged 21-60 years

ASA physical status I or II

Scheduled for elective upper limb surgery below the elbow

Provided written

Treatment and study plan

Bupivacaine + saline

Drug

25 ml of 0.5% bupivacaine combined with 5 ml of normal saline, administered via ultrasound-guided supraclavicular brachial plexus block as a control intervention

Bupivacaine + nalbuphine

Drug

25 ml of 0.5% bupivacaine combined with nalbuphine at a dose of 50 µg/kg, administered via ultrasound-guided supraclavicular brachial plexus block

Bupivacaine + morphine

Drug

25 ml of 0.5% bupivacaine combined with morphine at a dose of 50 µg/kg, administered via ultrasound-guided supraclavicular brachial plexus block

Primary outcomes

  1. Analgesic Duration

    Time frame: 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.

Secondary outcomes

  1. Total Postoperative Analgesic Consumption

    Time frame: Within 24 hours postoperatively

    Total amount (in grams) of paracetamol administered as rescue analgesia during the first 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Alzahraa Ahmed Abbas

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.