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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07008443
Enrollment
60
Registered
2025-06-06
Start date
2024-01-01
Completion date
2025-04-01
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia Block, Upper Limb Surgery

Keywords

Nerve Block Adjuvants Regional Anesthesia, AI Prediction

Brief summary

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.

Detailed description

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.

Interventions

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

DRUGBupivacaine + nalbuphine

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

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

Sponsors

Alzahraa Ahmed Abbas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

Three-arm parallel design with random assignment to bupivacaine alone, bupivacaine + nalbuphine, or bupivacaine + morphine

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analgesic DurationFrom 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

MeasureTime frameDescription
Total Postoperative Analgesic ConsumptionWithin 24 hours postoperativelyTotal amount (in grams) of paracetamol administered as rescue analgesia during the first 24 hours postoperatively.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026