Clavicle FractureWALANT-CPBNCT06106399
US Guided WALLANT vs CPB Block for Clavicle Surgery
A study testing WALLANT in people with Clavicle Fracture and Clavicle Injury, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The clavicle is frequently fractured bone. regional anesthesia (RA) for clavicle surgery is always challenging due t complex innervation from the two plexuses (cervical and brachial). various RA techniques described for clavicle surgery include plexus blocks, fascial plane blocks,and truncal blocks. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Clavicle Fracture, Clavicle Injury
- What is being tested?
- WALLANT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Mar 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists (ASA) 1,2
- Unilateral clavicle fracture.
Who cannot join
- psychologically unstable patient.
- uncooperative patient.
- patient refusal to be awake during surgery.
- allergy.
- infection at site of infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar University
Cairo, Naser City, 11811
Ahmed M Selim, director, 0020222611404, info@azhar.edu.eg
About this study
Official title: Ultrasound Guided Wide Awake Local Anesthesia Versus Clavipectoral Fascia Plane Block With Superficial Cervical Plexus Block for Clavicle Surgery, Prospective Randomized Clinical Trial
The clavicle is frequently fractured bone. regional anesthesia (RA) for clavicle surgery is always challenging due t complex innervation from the two plexuses (cervical and brachial). various RA techniques described for clavicle surgery include plexus blocks, fascial plane blocks,and truncal blocks.
Read the detailed description
Clavipectoral Fascial Plane Block (CPB) is most commonly used as an anesthesia and postoperative analgesia technique to clavicle surgery.
This study is deigned to evaluate the feasibility of wide awake local anesthesia no tourniquet (WALANT) technique as a sole anesthesia in clavicle surgery, clavipectoral (CVP) fascia plane block + superficial cervical plexus plane block (CPB) as a sole anesthesia technique in clavicle surgery by using intraoperative verbal rating score (VRS) to determine how many patients need analgesia, sedation or convert to general anesthesia (GA), and postoperative assessment of patient satisfaction and 24 hour postoperative opioid consumption.
- Conditions
- Clavicle Fracture, Clavicle Injury
- Being tested
- WALLANT
- Keywords
- wide awake local anesthesia, clavipectoral fascia plane block, clavicle surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALLANTProcedure or surgery
Also called CPB
Comparison between (WALLANT) and (CPB) as a sole anesthesia in clavicle surgery
| Study group | Role | What they receive |
|---|---|---|
| WALLANT (group 1) | Active comparator | wide awake local anesthesia and no tourniquet (WALLANT) Receives: Procedure: WALLANT |
| CPB (group 2) | Active comparator | clavipectoral fascia plane block combined with superficial cervical plexus block (CPB) Receives: Procedure: WALLANT |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the block as a sole anesthetic technique
intra-operative verbal rating score to determine how many patients need supplementary analgesia,sedation or converted to general anesthesia
Measured: 6 months
Secondary outcomes (2)
24 hour postoperative opioid consumption
Post-operative hourly VAS for the first 6 hours, at 8 hours, at 12 hours, at 16 hours,then at 24 hours postoperative
Measured: 6 months
patient satisfaction
patient satisfaction score immediately postoperative on hospital discharge and after 24 hours
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Arms model
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Mohamed Abdelgawad Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106399
- Sponsor's protocol ID
- WALANT-CPB in clavicle surgery
- Acronym
- WALANT-CPB
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are planned to be coded for privacy protection
Publications
Zhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, Wang L. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Sep 1;135(3):633-640. doi: 10.1213/ANE.0000000000005911. Epub 2022 Jan 21.
PubMed 35061634Lee CCM, Beh ZY, Lua CB, Peng K, Fathil SM, Hou JD, Lin JA. Regional Anesthetic and Analgesic Techniques for Clavicle Fractures and Clavicle Surgeries: Part 1-A Scoping Review. Healthcare (Basel). 2022 Aug 7;10(8):1487. doi: 10.3390/healthcare10081487.
PubMed 36011144Azizi K, Benhamza S, Motiaa Y. Novel use of ultrasound guidance in wide-awake local anesthesia technique for clavicle surgery. Korean J Anesthesiol. 2022 Feb;75(1):103-105. doi: 10.4097/kja.21282. Epub 2021 Jun 30. No abstract available.
PubMed 35124948
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Wide Awake Local Anesthesia Versus Clavipectoral Fascia Plane Block With Superficial Cervical Plexus Block for Clavicle Surgery, Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06106399
- Acronym / sponsor ID
- WALANT-CPB / WALANT-CPB in clavicle surgery
- Conditions
- Clavicle Fracture, Clavicle Injury
- Keywords
- wide awake local anesthesia, clavipectoral fascia plane block, clavicle surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 Oct 2023 (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 clavicle is frequently fractured bone. regional anesthesia (RA) for clavicle surgery is always challenging due t complex innervation from the two plexuses (cervical and brachial). various RA techniques described for clavicle surgery include plexus blocks, fascial plane blocks,and truncal blocks.
Detailed description
Clavipectoral Fascial Plane Block (CPB) is most commonly used as an anesthesia and postoperative analgesia technique to clavicle surgery.
This study is deigned to evaluate the feasibility of wide awake local anesthesia no tourniquet (WALANT) technique as a sole anesthesia in clavicle surgery, clavipectoral (CVP) fascia plane block + superficial cervical plexus plane block (CPB) as a sole anesthesia technique in clavicle surgery by using intraoperative verbal rating score (VRS) to determine how many patients need analgesia, sedation or convert to general anesthesia (GA), and postoperative assessment of patient satisfaction and 24 hour postoperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 Arms model
| Arm | Type | Receives |
|---|---|---|
| WALLANT (group 1) | Active comparator | Procedure: WALLANTwide awake local anesthesia and no tourniquet (WALLANT) |
| CPB (group 2) | Active comparator | Procedure: WALLANTclavipectoral fascia plane block combined with superficial cervical plexus block (CPB) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists (ASA) 1,2
- Unilateral clavicle fracture.
Key exclusion criteria (5 listed)
- psychologically unstable patient.
- uncooperative patient.
- patient refusal to be awake during surgery.
- allergy.
- infection at site of infection.
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 |
|---|---|---|
| WALLANTAlso: CPBComparison between (WALLANT) and (CPB) as a sole anesthesia in clavicle surgery | Procedure or surgery | CPB (group 2), WALLANT (group 1) |
Primary outcome
efficacy of the block as a sole anesthetic technique
Time frame: 6 months
intra-operative verbal rating score to determine how many patients need supplementary analgesia,sedation or converted to general anesthesia
2 secondary outcomes
24 hour postoperative opioid consumption
Time frame: 6 months
patient satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Background: PubMed 35061634Zhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, Wang L. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Sep 1;135(3):633-640. doi: 10.1213/ANE.0000000000005911. Epub 2022 Jan 21.
- Background: PubMed 36011144Lee CCM, Beh ZY, Lua CB, Peng K, Fathil SM, Hou JD, Lin JA. Regional Anesthetic and Analgesic Techniques for Clavicle Fractures and Clavicle Surgeries: Part 1-A Scoping Review. Healthcare (Basel). 2022 Aug 7;10(8):1487. doi: 10.3390/healthcare10081487.
- Background: PubMed 35124948Azizi K, Benhamza S, Motiaa Y. Novel use of ultrasound guidance in wide-awake local anesthesia technique for clavicle surgery. Korean J Anesthesiol. 2022 Feb;75(1):103-105. doi: 10.4097/kja.21282. Epub 2021 Jun 30. No abstract available.
- Individual participant dataSharing planned: No. IPD are planned to be coded for privacy protection
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WALLANT in people with Clavicle Fracture and Clavicle Injury, run by Al-Azhar 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail M Ahmed, Prof (00201117310053, ismailabdelgawad.623@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of the block as a sole anesthetic technique (time frame: 6 months). 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 NCT06106399, which also lists 3 linked publications.
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 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.