Regional Anesthesia BlockPhase 4NCT07008443
An Integrated Artificial Intelligence Approach for Predicting Analgesic Time Based on Nalbuphine Versus Morphine as Adjuvants to Bupivacaine in Ultrasound-Guided Supraclavicular Block
A Phase 4 study testing Bupivacaine + saline, Bupivacaine + nalbuphine and Bupivacaine + morphine in people with Regional Anesthesia Block and Upper Limb Surgery, run by Alzahraa Ahmed Abbas at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Regional Anesthesia Block, Upper Limb Surgery
- What is being tested?
- Bupivacaine + saline, Bupivacaine + nalbuphine and Bupivacaine + morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 21-60 years
- ASA physical status I or II
- Scheduled for elective upper limb surgery below the elbow
- Provided written
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Regional Anesthesia Block, Upper Limb Surgery
- Being tested
- Bupivacaine + saline, Bupivacaine + nalbuphine, Bupivacaine + morphine
- Keywords
- Nerve Block Adjuvants Regional Anesthesia, AI Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + salineDrug
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 + nalbuphineDrug
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 + morphineDrug
25 ml of 0.5% bupivacaine combined with morphine at a dose of 50 µg/kg, administered via ultrasound-guided supraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Drug: Bupivacaine + morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From block administration to first request for postoperative analgesia (up to 24 hours)
Secondary outcomes (1)
Total Postoperative Analgesic Consumption
Total amount (in grams) of paracetamol administered as rescue analgesia during the first 24 hours postoperatively.
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel design with random assignment to bupivacaine alone, bupivacaine + nalbuphine, or bupivacaine + morphine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzahraa Ahmed Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alzahraa Ahmed Abbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008443
- Sponsor's protocol ID
- AI-Supraclavicular-Trial-2025
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbas AA, Ghoneim S, Sharf M, Farag A. Effect of nalbuphine and morphine as adjuvants to bupivacaine in ultrasound-guided supraclavicular block: a randomized controlled trial with machine learning-based predictive analysis. BMC Anesthesiol. 2025 Dec 28;26(1):68. doi: 10.1186/s12871-025-03537-6.
PubMed 41455918
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Artificial Intelligence Approach for Predicting Analgesic Time Based on Nalbuphine Versus Morphine as Adjuvants to Bupivacaine in Ultrasound-Guided Supraclavicular Block
- ClinicalTrials.gov ID
- NCT07008443
- Acronym / sponsor ID
- AI-Supraclavicular-Trial-2025
- Conditions
- Regional Anesthesia Block, Upper Limb Surgery
- Keywords
- Nerve Block Adjuvants Regional Anesthesia, AI Prediction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alzahraa Ahmed AbbasUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel design with random assignment to bupivacaine alone, bupivacaine + nalbuphine, or bupivacaine + morphine
| Arm | Type | Receives |
|---|---|---|
| Control Group (Bupivacaine + Saline) | Active comparator | Drug: Bupivacaine + salineParticipants received 25 ml of 0.5% bupivacaine plus 5 ml of normal saline via ultrasound-guided supraclavicular brachial plexus block. |
| Nalbuphine Group (Bupivacaine + Nalbuphine) | Experimental | Drug: Bupivacaine + nalbuphineParticipants received 25 ml of 0.5% bupivacaine plus nalbuphine at 50 µg/kg via ultrasound-guided supraclavicular brachial plexus block |
| Morphine Group (Bupivacaine + Morphine) | Experimental | Drug: Bupivacaine + morphineParticipants received 25 ml of 0.5% bupivacaine plus morphine at 50 µg/kg via ultrasound-guided supraclavicular brachial plexus block. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients aged 21-60 years
- ASA physical status I or II
- Scheduled for elective upper limb surgery below the elbow
- Provided written
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine + saline25 ml of 0.5% bupivacaine combined with 5 ml of normal saline, administered via ultrasound-guided supraclavicular brachial plexus block as a control intervention | Drug | Control Group (Bupivacaine + Saline) |
| Bupivacaine + nalbuphine25 ml of 0.5% bupivacaine combined with nalbuphine at a dose of 50 µg/kg, administered via ultrasound-guided supraclavicular brachial plexus block | Drug | Nalbuphine Group (Bupivacaine + Nalbuphine) |
| Bupivacaine + morphine25 ml of 0.5% bupivacaine combined with morphine at a dose of 50 µg/kg, administered via ultrasound-guided supraclavicular brachial plexus block | Drug | Morphine Group (Bupivacaine + Morphine) |
Primary outcome
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.
1 secondary outcome
Total Postoperative Analgesic Consumption
Time frame: Within 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 41455918Abbas AA, Ghoneim S, Sharf M, Farag A. Effect of nalbuphine and morphine as adjuvants to bupivacaine in ultrasound-guided supraclavicular block: a randomized controlled trial with machine learning-based predictive analysis. BMC Anesthesiol. 2025 Dec 28;26(1):68. doi: 10.1186/s12871-025-03537-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine + saline, Bupivacaine + nalbuphine and Bupivacaine + morphine in people with Regional Anesthesia Block and Upper Limb Surgery, run by Alzahraa Ahmed Abbas at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Duration (time frame: From block administration to first request for postoperative analgesia (up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.