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

NCT07008443 | Completed Phase 4

• 1 other identifier: AI-Supraclavicular-Trial-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Block; Upper Limb Surgery

Keywords

Nerve Block Adjuvants Regional Anesthesia; AI Prediction

Outcome Measures

Primary Outcomes (1)

• Analgesic Duration

  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.

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

Secondary Outcomes (1)

• Total Postoperative Analgesic Consumption

  Within 24 hours postoperatively

Study Arms (3)

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.

Drug: Bupivacaine + saline

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

Drug: Bupivacaine + nalbuphine

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.

Drug: Bupivacaine + morphine

Interventions

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

Control Group (Bupivacaine + Saline)

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

Nalbuphine Group (Bupivacaine + Nalbuphine)

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

Morphine Group (Bupivacaine + Morphine)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Alzahraa Ahmed Abbas: lead

Study Sites (1)

Al-Zahraa University Hospital

Cairo, Alexandria Governorate, 21415, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride; Nalbuphine; Morphine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization and drug preparation were concealed in sealed envelopes. Blinding was maintained for participants, providers, and data analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Damietta Faculty of Medicine, Al-Azhar University

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

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)