Hand SurgeryPhase 4NCT06847620
Effect of Verapamil as an Adjuvant to Local Anaethetics in Supraclav Block for Hand Surgery
A Phase 4 study testing Supraclavicular Brachial Plexus Block, Bupivacaine 0.25% 20ml alone and bupivacaine 0.25% And verapamil in people with Hand Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Surgery
- What is being tested?
- Supraclavicular Brachial Plexus Block, Bupivacaine 0.25% 20ml alone and bupivacaine 0.25% And verapamil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 15 Oct 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 21-70 years old
- Patients with ASA I / II
- patients undergoing hand surgeries
Who cannot join
- Patients refusal
- Skin infection at the injection site.
- Contraindications to regional anaesthesia as bleeding disorders
- Allergy to bupivacaine or other drugs involved in the study.
- Uncooperative patients.
- BMI >35
- Patients taking medications for psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Verapamil When Added to Bupivacaine in Ultrasound-guided Supraclavicular Block in Hand Surgeries
The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia.
Read the detailed description
Preoperative Period All patients will clinically be assessed and routine preoperative investigations will be done: Complete blood picture, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG. The initial vital data will be measured after applying the standard monitoring including pulse oximetry, non-invasive blood pressure and ECG. All patients will be admitted after fasting for 6 hours.
Intraoperative Period On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. Intravenous (IV) line will be inserted and IV lactated Ringer will be started.
The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.
Under aseptic conditions, the ultrasound probe will be situated parallel to the clavicle in the supraclavicular area to show the plexus as a "bunch of grapes" or as having a "honeycomb" appearance. The block will be done with a short beveled echogenic needle 5 cm, 22 G for optimal control and visibility. The predetermined volume of 22 ml will be injected around the brachial plexus after negative aspiration to avoid inadvertent intravascular injection keeping in mind adequate block of lower trunk. Distension of brachial plexus sheath will be regarded as an indication of successful block "Donut sign". A massage for 5 min will be applied to aid an equal volume distribution.
- Conditions
- Hand Surgery
- Being tested
- Supraclavicular Brachial Plexus Block, Bupivacaine 0.25% 20ml alone, bupivacaine 0.25% And verapamil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular Brachial Plexus BlockProcedure or surgery
The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.
Bupivacaine 0.25% 20ml aloneDrug
will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.
bupivacaine 0.25% And verapamilDrug
will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg
| Study group | Role | What they receive |
|---|---|---|
| • Group A (the control group) | Active comparator | group A: will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline. Receives: Procedure: Supraclavicular Brachial Plexus Block; Drug: Bupivacaine 0.25% 20ml alone |
| Group B | Active comparator | Group B : will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg) Receives: Procedure: Supraclavicular Brachial Plexus Block; Drug: bupivacaine 0.25% And verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Duration between performing the block and the need of rescue analgesia in patients receiving ultrasound-guided supraclavicular Brachial plexus block with bupivacaine as sole agent versus bupivacaine and verapamil.
Measured: The duration from giving the block till the need of rescue analgesia in post op 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2024
- Primary completion4 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847620
- Sponsor's protocol ID
- FMASU MS165/2024
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Verapamil When Added to Bupivacaine in Ultrasound-guided Supraclavicular Block in Hand Surgeries
- ClinicalTrials.gov ID
- NCT06847620
- Acronym / sponsor ID
- FMASU MS165/2024
- Conditions
- Hand Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 26 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.
The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia.
Detailed description
Preoperative Period All patients will clinically be assessed and routine preoperative investigations will be done: Complete blood picture, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG. The initial vital data will be measured after applying the standard monitoring including pulse oximetry, non-invasive blood pressure and ECG. All patients will be admitted after fasting for 6 hours.
Intraoperative Period On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. Intravenous (IV) line will be inserted and IV lactated Ringer will be started.
The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.
Under aseptic conditions, the ultrasound probe will be situated parallel to the clavicle in the supraclavicular area to show the plexus as a "bunch of grapes" or as having a "honeycomb" appearance. The block will be done with a short beveled echogenic needle 5 cm, 22 G for optimal control and visibility. The predetermined volume of 22 ml will be injected around the brachial plexus after negative aspiration to avoid inadvertent intravascular injection keeping in mind adequate block of lower trunk. Distension of brachial plexus sheath will be regarded as an indication of successful block "Donut sign". A massage for 5 min will be applied to aid an equal volume distribution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Group A (the control group) | Active comparator | Procedure: Supraclavicular Brachial Plexus Block, Drug: Bupivacaine 0.25% 20ml alonegroup A: will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline. |
| Group B | Active comparator | Procedure: Supraclavicular Brachial Plexus Block, Drug: bupivacaine 0.25% And verapamilGroup B : will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 21-70 years old
- Patients with ASA I / II
- patients undergoing hand surgeries
Key exclusion criteria (7 listed)
- Patients refusal
- Skin infection at the injection site.
- Contraindications to regional anaesthesia as bleeding disorders
- Allergy to bupivacaine or other drugs involved in the study.
- Uncooperative patients.
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 |
|---|---|---|
| Supraclavicular Brachial Plexus BlockThe block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes. | Procedure or surgery | Group B, • Group A (the control group) |
| Bupivacaine 0.25% 20ml alonewill receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline. | Drug | • Group A (the control group) |
| bupivacaine 0.25% And verapamilwill receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg | Drug | Group B |
Primary outcome
Primary outcome measure
Time frame: The duration from giving the block till the need of rescue analgesia in post op 24 hours
Duration between performing the block and the need of rescue analgesia in patients receiving ultrasound-guided supraclavicular Brachial plexus block with bupivacaine as sole agent versus bupivacaine and verapamil.
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 26 Feb 2025.
- Individual participant dataSharing planned: Yes
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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 Supraclavicular Brachial Plexus Block, Bupivacaine 0.25% 20ml alone and bupivacaine 0.25% And verapamil in people with Hand Surgery, run by Ain Shams University 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 3 inclusion and 7 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 26 Feb 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?
Primary outcome measure (time frame: The duration from giving the block till the need of rescue analgesia in post op 24 hours). 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 26 Feb 2025.