Hand SurgeriesPhase 4NCT06826690
Comparative Factorial Study Design of Ultrasound Guided Wrist Block for Hand Surgery Comparing Effect of Bupivacane Alone and Bupivacane With Dexamethasone and Bupivacane With Dexametmiodine and Bupivacane With Dexamethasone and Dexametmiodine
A Phase 4 study testing Group 1: ultrasound guided wrist block with bupivacane alone, Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone and Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine in people with Hand Surgeries, run by Mahmoud Rafaat Mohamed at 1 site in Egypt.
Trial summary
Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hand Surgeries
- What is being tested?
- Group 1: ultrasound guided wrist block with bupivacane alone, Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone and Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2025to 30 Mar 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients equal 18-50 years old and are ASA I- II
Who cannot join
- allergy to used medication
- pre exist neuropathy
- coagulapthy
- cognitive impairment
- refusal to participate
- Failed block and requiring general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Factorial Study Design of Adjuvant Enhanced Ultrasound-Guided Wrist Block Anaesthesia for Hand Surgery : Bupivacane, Dexamethasone, Dexametmiodine
Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine
Read the detailed description
Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexametmiodine and dexamethasone.
Taking medical and surgical history from patients. Taking base line data as heart rate and blood pressure and spo2. Measure duration of analgesia for post operative pain using NRS for 24 hours abd recording NRS at time interval of 2 , 4,6,12,24 hours post operative.
Any patient the NRS above 4 will receive 5 mg nalbufin . Recording patients satisfaction by a survey .
- Conditions
- Hand Surgeries
- Being tested
- Group 1: ultrasound guided wrist block with bupivacane alone, Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone, Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: ultrasound guided wrist block with bupivacane aloneProcedure or surgery
Ultrasound guided wrist block with 15 ml volume of bupivacane.25%
Group 2 : ultrasound guided wrist block with bupivacane and dexamethasoneProcedure or surgery
Group 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally
Group 3: ultrasound guided wrist block with bupivacane and dexametmiodineProcedure or surgery
Group 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally
Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineProcedure or surgery
Group 4 patients will receive ultrasound guided wrist block with bupivacan.25%e and 8 mg dexamethasone and 50 mcg dexametmiodine
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ultrasound guided wrist block with bupivacane alone | Active comparator | Group 1: ultrasound guided wrist block with bupivacane.025% .. 15 ml volume totally Receives: Procedure: Group 1: ultrasound guided wrist block with bupivacane alone; Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone; Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine; Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine |
| Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone | Active comparator | Group 2: 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone Receives: Procedure: Group 1: ultrasound guided wrist block with bupivacane alone; Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone; Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine; Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine |
| Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine | Active comparator | Group 3: 40 patients receive ultrasound guided wrist block with 15 ml volume totally including bupivacane.25% and 50 mcg dexametmiodine Receives: Procedure: Group 1: ultrasound guided wrist block with bupivacane alone; Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone; Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine; Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine |
| Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone | Active comparator | Group 4 : 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone and 50 mcg dexametmiodine Receives: Procedure: Group 1: ultrasound guided wrist block with bupivacane alone; Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone; Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine; Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia
Dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia, defined as the difference-in-differences contrast (D-C)-(B-A), measured from completion of the wrist block to the first request for rescue analgesia, within 24 hours.
Measured: From completion of the ultrasound-guided wrist block until the first request for rescue analgesia, assessed during the first 24 hours after the block
Secondary outcomes (8)
Postoperative pain intensity measured by the Numeric Rating Scale (NRS)
Postoperative pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were recorded at prespecified postoperative time points.
Measured: At 6, 12, 16, 18, and 24 hours after completion of the ultrasound-guided wrist block
Total rescue nalbuphine consumption during the first 24 hours after surgery
Total amount of intravenous nalbuphine administered as rescue analgesia during the first 24 hours after surgery. Rescue nalbuphine (5 mg intravenously) was administered when the Numeric Rating Scale pain score was ≥4. The total dose received by each participant was recorded in milligrams.
Measured: From completion of surgery through 24 hours postoperatively
Intraoperative hemodynamics parameters.
Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and peripheral oxygen saturation were recorded during the perioperative period. Measurements were obtained at 10-minute intervals during the first 120 minutes after initiation of the block and at arrival to and discharge from the post-anesthesia care unit.
Measured: Every 10 minutes from 10 to 120 minutes after completion of the ultrasound-guided wrist block, and at post-anesthesia care unit arrival and discharge
Incidence of perioperative adverse events
Incidence of prespecified perioperative adverse events, including hypotension, bradycardia, and allergic reactions. Hypotension and bradycardia were recorded according to the study's prespecified clinical definitions and any event requiring clinical intervention was documented.
Measured: From completion of the ultrasound-guided wrist block until 24 hours postoperatively
Patient satisfaction with perioperative anesthesia care
Patient satisfaction was assessed using a validated single-item 0-100 mm Global Satisfaction Visual Analog Scale, where 0 mm indicates complete dissatisfaction and 100 mm indicates complete satisfaction. Scores of 0-39 mm, 40-59 mm, 60-79 mm, and 80-100 mm were categorized as dissatisfied, moderately satisfied, satisfied, and very satisfied, respectively.
Measured: At 24 hours after surgery
Duration of postoperative analgesia
Time from completion of the ultrasound-guided wrist block to the participant's first request for rescue analgesia. Rescue analgesia was administered when the Numeric Rating Scale (NRS) pain score was ≥4. The duration was recorded in hours from completion of the block until the first rescue analgesic request.
Measured: From completion of the ultrasound-guided wrist block until the first request for rescue analgesia, assessed during the first 24 hours after the block
Dexamethasone × dexmedetomidine interaction on 24-hour rescue nalbuphine consumption
The interaction between dexamethasone and dexmedetomidine on total rescue nalbuphine consumption was assessed using the prespecified 2×2 factorial analysis. The interaction was quantified as the difference-in-differences contrast between the four randomized treatment groups.
Measured: From completion of surgery through 24 hours postoperatively
Dexamethasone × dexmedetomidine interaction on postoperative pain intensity at 24 hours
The interaction between dexamethasone and dexmedetomidine on postoperative pain intensity at 24 hours was assessed using the prespecified 2×2 factorial analysis.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start30 Mar 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Rafaat Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Rafaat Mohamed, Aswan University
- Investigators
- Zaher Zaki Zaher, Specialist, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826690
- Sponsor's protocol ID
- 963-9-24
- Status last verified
- Aug 2024
- First submitted
- 10 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Factorial Study Design of Adjuvant Enhanced Ultrasound-Guided Wrist Block Anaesthesia for Hand Surgery : Bupivacane, Dexamethasone, Dexametmiodine
- ClinicalTrials.gov ID
- NCT06826690
- Acronym / sponsor ID
- 963-9-24
- Conditions
- Hand Surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mahmoud Rafaat MohamedUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 14 Feb 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.
Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine
Detailed description
Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexametmiodine and dexamethasone.
Taking medical and surgical history from patients. Taking base line data as heart rate and blood pressure and spo2. Measure duration of analgesia for post operative pain using NRS for 24 hours abd recording NRS at time interval of 2 , 4,6,12,24 hours post operative.
Any patient the NRS above 4 will receive 5 mg nalbufin . Recording patients satisfaction by a survey .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: ultrasound guided wrist block with bupivacane alone | Active comparator | Procedure: Group 1: ultrasound guided wrist block with bupivacane alone, Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone, Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineGroup 1: ultrasound guided wrist block with bupivacane.025% .. 15 ml volume totally |
| Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone | Active comparator | Procedure: Group 1: ultrasound guided wrist block with bupivacane alone, Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone, Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineGroup 2: 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone |
| Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine | Active comparator | Procedure: Group 1: ultrasound guided wrist block with bupivacane alone, Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone, Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineGroup 3: 40 patients receive ultrasound guided wrist block with 15 ml volume totally including bupivacane.25% and 50 mcg dexametmiodine |
| Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone | Active comparator | Procedure: Group 1: ultrasound guided wrist block with bupivacane alone, Procedure: Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone, Procedure: Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Procedure: Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineGroup 4 : 40 patients receive ultrasound guided wrist block with 15 ml volume including bupivacane.25% and 8 mg dexamethasone and 50 mcg dexametmiodine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients equal 18-50 years old and are ASA I- II
Key exclusion criteria (6 listed)
- allergy to used medication
- pre exist neuropathy
- coagulapthy
- cognitive impairment
- refusal to participate
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 |
|---|---|---|
| Group 1: ultrasound guided wrist block with bupivacane aloneUltrasound guided wrist block with 15 ml volume of bupivacane.25% | Procedure or surgery | Group 1: ultrasound guided wrist block with bupivacane alone, Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone, Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone |
| Group 2 : ultrasound guided wrist block with bupivacane and dexamethasoneGroup 2 : patients receive ultrasound guided wrist block with bupivacane.25% and 8 mg dexamethasone.. 15 ml volume totally | Procedure or surgery | Group 1: ultrasound guided wrist block with bupivacane alone, Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone, Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone |
| Group 3: ultrasound guided wrist block with bupivacane and dexametmiodineGroup 3 will receive ultrasound guided wrist block with bupivacane.25% and 50 mcg dexametmiodine... 15 ml volume totally | Procedure or surgery | Group 1: ultrasound guided wrist block with bupivacane alone, Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone, Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone |
| Group 4: patients will receive ultrasound guided wrist block with bupivacane and dexamethasone and dexametmiodineGroup 4 patients will receive ultrasound guided wrist block with bupivacan.25%e and 8 mg dexamethasone and 50 mcg dexametmiodine | Procedure or surgery | Group 1: ultrasound guided wrist block with bupivacane alone, Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine, Group 4: ultrasound guided wrist block with bupivacane and dexametmiodine and dexamethasone, Group2: ultrasound guided wrist block with bupivacane.25% and 8mg dexamethasone |
Primary outcome
Dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia
Time frame: From completion of the ultrasound-guided wrist block until the first request for rescue analgesia, assessed during the first 24 hours after the block
Dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia, defined as the difference-in-differences contrast (D-C)-(B-A), measured from completion of the wrist block to the first request for rescue analgesia, within 24 hours.
8 secondary outcomes
Postoperative pain intensity measured by the Numeric Rating Scale (NRS)
Time frame: At 6, 12, 16, 18, and 24 hours after completion of the ultrasound-guided wrist block
Total rescue nalbuphine consumption during the first 24 hours after surgery
Time frame: From completion of surgery through 24 hours postoperatively
Intraoperative hemodynamics parameters.
Time frame: Every 10 minutes from 10 to 120 minutes after completion of the ultrasound-guided wrist block, and at post-anesthesia care unit arrival and discharge
Incidence of perioperative adverse events
Time frame: From completion of the ultrasound-guided wrist block until 24 hours postoperatively
Patient satisfaction with perioperative anesthesia care
Time frame: At 24 hours after surgery
Duration of postoperative analgesia
Time frame: From completion of the ultrasound-guided wrist block until the first request for rescue analgesia, assessed during the first 24 hours after the block
Dexamethasone × dexmedetomidine interaction on 24-hour rescue nalbuphine consumption
Time frame: From completion of surgery through 24 hours postoperatively
Dexamethasone × dexmedetomidine interaction on postoperative pain intensity at 24 hours
Time frame: At 24 hours after surgery
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zaher Zaki Zaher, Specialist study director
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 Group 1: ultrasound guided wrist block with bupivacane alone, Group 2 : ultrasound guided wrist block with bupivacane and dexamethasone and Group 3: ultrasound guided wrist block with bupivacane and dexametmiodine in people with Hand Surgeries, run by Mahmoud Rafaat Mohamed 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 1 inclusion and 6 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 30 Sep 2026. 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?
Dexamethasone × dexmedetomidine interaction on duration of postoperative analgesia (time frame: From completion of the ultrasound-guided wrist block until the first request for rescue analgesia, assessed during the first 24 hours after the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.