UltrasoundNCT06831604
Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia
A study testing Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB) and Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP) in people with Ultrasound and Superficial Cervical Plexus Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasound, Superficial Cervical Plexus Block, Clavipectoral Fascial Plane Block
- What is being tested?
- Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB) and Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Patients with unilateral clavicular fractures undergo elective internal fixation of clavicle fractures.
Who cannot join
- Coagulopathy.
- Patients with infection at block site.
- Allergy to local anesthetics.
- Patient with morbid obesity (body mass index >35 kg/m2).
- Pre-existing neurological disease.
- Difficult communication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Ahmed M Aboeldahab, Master, 00201069784512, ahmed.aboeldahab1422@gmail.com
Kamal E Haikal, MD
About this study
Official title: Ultrasound Guided Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia: A Randomized Controlled Trial
This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries.
Read the detailed description
Clavicular fracture is the most common injury in the shoulder, it occurs in 35% of shoulder girdle fractures. Clavicle surgeries often involve addressing fractures, dislocations, or corrective procedures, and they generally require precise and effective pain control.
Traditional superficial cervical plexus block (SCPB) combined with interscalene brachial plexus block (ISBP) can be used in the operation of clavicle fracture.
The SCPB targets the cervical plexus, providing sensory anesthesia to the skin overlying the cervical and upper thoracic regions. It is often used in conjunction with other blocks to enhance analgesia in the upper shoulder and clavicle area.
The ISBP block involves the administration of local anesthetic at the level of the brachial plexus, typically performed between the anterior and middle scalene muscles. This approach provides comprehensive analgesia for the shoulder, upper arm, and part of the clavicular area.
Clavipectoral fascial plane block (CPB) is a new regional nerve block and can be used in anesthesia and postoperative analgesia for clavicle fracture surgery. CPB provides analgesia to the clavicular region and the upper shoulder.
- Conditions
- Ultrasound, Superficial Cervical Plexus Block, Clavipectoral Fascial Plane Block, Interscalene Brachial Block, Clavicle Surgeries
- Being tested
- Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB), Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB)Drug
Also called Group I
Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB).
Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)Drug
Also called Group II
Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB). Receives: Drug: Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB) |
| Group II | Experimental | Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP). Receives: Drug: Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The block will be considered successful when complete sensory block is achieved within 45 min after injection of the study drug and inadequate block will be converted to general anesthesia and excluded from the study.
Measured: Intraoperatively
Secondary outcomes (4)
First request of the rescue analgesia
First request of the rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated
Measured: 24 hours postoperatively
Total morphine consumption
Rescue analgesia of morphine will be given as 2 mg bolus if the visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4. Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of Complications
Incidence of complications as local anesthetic systemic toxicity, nerve injury, diaphragmatic paresis, pneumothorax and high epidural block.
Measured: 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 posted18 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Aboeldahab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831604
- Sponsor's protocol ID
- 36265MD331/12/24
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06831604
- Acronym / sponsor ID
- 36265MD331/12/24
- Conditions
- Ultrasound, Superficial Cervical Plexus Block, Clavipectoral Fascial Plane Block, Interscalene Brachial Block, Clavicle Surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 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.
This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries.
Detailed description
Clavicular fracture is the most common injury in the shoulder, it occurs in 35% of shoulder girdle fractures. Clavicle surgeries often involve addressing fractures, dislocations, or corrective procedures, and they generally require precise and effective pain control.
Traditional superficial cervical plexus block (SCPB) combined with interscalene brachial plexus block (ISBP) can be used in the operation of clavicle fracture.
The SCPB targets the cervical plexus, providing sensory anesthesia to the skin overlying the cervical and upper thoracic regions. It is often used in conjunction with other blocks to enhance analgesia in the upper shoulder and clavicle area.
The ISBP block involves the administration of local anesthetic at the level of the brachial plexus, typically performed between the anterior and middle scalene muscles. This approach provides comprehensive analgesia for the shoulder, upper arm, and part of the clavicular area.
Clavipectoral fascial plane block (CPB) is a new regional nerve block and can be used in anesthesia and postoperative analgesia for clavicle fracture surgery. CPB provides analgesia to the clavicular region and the upper shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB)Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB). |
| Group II | Experimental | Drug: Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Patients with unilateral clavicular fractures undergo elective internal fixation of clavicle fractures.
Key exclusion criteria (6 listed)
- Coagulopathy.
- Patients with infection at block site.
- Allergy to local anesthetics.
- Patient with morbid obesity (body mass index >35 kg/m2).
- Pre-existing neurological disease.
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 |
|---|---|---|
| Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB)Also: Group IPatients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB). | Drug | Group I |
| Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)Also: Group IIPatients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP) | Drug | Group II |
Primary outcome
Success rate
Time frame: Intraoperatively
The block will be considered successful when complete sensory block is achieved within 45 min after injection of the study drug and inadequate block will be converted to general anesthesia and excluded from the study.
4 secondary outcomes
First request of the rescue analgesia
Time frame: 24 hours postoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of Complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB) and Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP) in people with Ultrasound and Superficial Cervical Plexus Block, run by Tanta 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 4 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: looking for participants now, as of the sponsor's last update on 11 Mar 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Aboeldahab, Master (00201069784512, ahmed.aboeldahab1422@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: Intraoperatively). 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 11 Mar 2025.