Brachial Plexus BlockadeNCT06820853
Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery.
A study testing Diaphragmatic excursion evaluation in people with Brachial Plexus Blockade, run by Cairo University at 1 site in Egypt.
Trial summary
Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block. Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brachial Plexus Blockade
- What is being tested?
- Diaphragmatic excursion evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2025to 19 May 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II undergoing shoulder surgery under GA
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery, a Randomized Controlled Trial
Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.
Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block
Read the detailed description
patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE
- Conditions
- Brachial Plexus Blockade
- Being tested
- Diaphragmatic excursion evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic excursion evaluationDevice
They will receive 10 ml of 0.5% bupivacaine over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Single shot | Active comparator | They will receive a 10 ml of 0.5 % bupivacaine as a single shot Receives: Device: Diaphragmatic excursion evaluation |
| Slow administration group | Active comparator | They will receive 10 ml of 0.5% bupivacaine over 10 minutes Receives: Device: Diaphragmatic excursion evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
defined as > 75% reduction in diaphragmatic excursion
Measured: baseline and 30 minutes after the block
Secondary outcomes (1)
partial phrenic block
25-50% reduction in DE
Measured: baseline and 30 minutes after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start16 Feb 2025
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus BlockadeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomly allocated into 2 groups : single shot group and slow infusion group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820853
- Sponsor's protocol ID
- interscalane block and DE
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available from corresponding author upon reasonable request
Publications
Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
PubMed 19920426Wong AK, Keeney LG, Chen L, Williams R, Liu J, Elkassabany NM. Effect of Local Anesthetic Concentration (0.2% vs 0.1% Ropivacaine) on Pulmonary Function, and Analgesia After Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Study. Pain Med. 2016 Dec;17(12):2397-2403. doi: 10.1093/pm/pnw057. Epub 2016 Apr 13.
PubMed 28025374Fujimura N, Namba H, Tsunoda K, Kawamata T, Taki K, Igarasi M, Namiki A. Effect of hemidiaphragmatic paresis caused by interscalene brachial plexus block on breathing pattern, chest wall mechanics, and arterial blood gases. Anesth Analg. 1995 Nov;81(5):962-6. doi: 10.1097/00000539-199511000-00012.
PubMed 7486085Verelst P, van Zundert A. Incidence of phrenic nerve block after interscalene brachial plexus block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):411-2; author reply 412. doi: 10.1097/AAP.0b013e318219e19d. No abstract available.
PubMed 21697691Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PubMed 16282408Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
PubMed 9924205Helmy MA, Gamal B, Milad LM, El Adawy A, Ibrahim F, Kasem SMM, Mostafa H. Single-shot versus slow infusion interscalene block and its impact on diaphragmatic function in patients undergoing shoulder surgery, a double blind randomized controlled trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101668. doi: 10.1016/j.accpm.2025.101668. Epub 2025 Nov 7.
PubMed 41207378
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06820853
- Acronym / sponsor ID
- interscalane block and DE
- Conditions
- Brachial Plexus Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 11 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.
Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.
Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block
Detailed description
patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- patients will be randomly allocated into 2 groups : single shot group and slow infusion group
| Arm | Type | Receives |
|---|---|---|
| Single shot | Active comparator | Device: Diaphragmatic excursion evaluationThey will receive a 10 ml of 0.5 % bupivacaine as a single shot |
| Slow administration group | Active comparator | Device: Diaphragmatic excursion evaluationThey will receive 10 ml of 0.5% bupivacaine over 10 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I or II undergoing shoulder surgery under GA
Key exclusion criteria (1 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 |
|---|---|---|
| Diaphragmatic excursion evaluationThey will receive 10 ml of 0.5% bupivacaine over 10 minutes | Device | Single shot, Slow administration group |
Primary outcome
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
Time frame: baseline and 30 minutes after the block
defined as > 75% reduction in diaphragmatic excursion
1 secondary outcome
partial phrenic block
Time frame: baseline and 30 minutes after the block
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 22 May 2025.
- Background: PubMed 19920426Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
- Background: PubMed 28025374Wong AK, Keeney LG, Chen L, Williams R, Liu J, Elkassabany NM. Effect of Local Anesthetic Concentration (0.2% vs 0.1% Ropivacaine) on Pulmonary Function, and Analgesia After Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Study. Pain Med. 2016 Dec;17(12):2397-2403. doi: 10.1093/pm/pnw057. Epub 2016 Apr 13.
- Results publication: PubMed 7486085Fujimura N, Namba H, Tsunoda K, Kawamata T, Taki K, Igarasi M, Namiki A. Effect of hemidiaphragmatic paresis caused by interscalene brachial plexus block on breathing pattern, chest wall mechanics, and arterial blood gases. Anesth Analg. 1995 Nov;81(5):962-6. doi: 10.1097/00000539-199511000-00012.
- Results publication: PubMed 21697691Verelst P, van Zundert A. Incidence of phrenic nerve block after interscalene brachial plexus block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):411-2; author reply 412. doi: 10.1097/AAP.0b013e318219e19d. No abstract available.
- Results publication: PubMed 16282408Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
- Results publication: PubMed 9924205Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
- Derived from this study: PubMed 41207378Helmy MA, Gamal B, Milad LM, El Adawy A, Ibrahim F, Kasem SMM, Mostafa H. Single-shot versus slow infusion interscalene block and its impact on diaphragmatic function in patients undergoing shoulder surgery, a double blind randomized controlled trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101668. doi: 10.1016/j.accpm.2025.101668. Epub 2025 Nov 7.
- Individual participant dataSharing planned: Undecided. Data will be available from corresponding author upon reasonable request
Related trials for Brachial Plexus Blockade
Recruiting
Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
Forearm Surgeries, Brachial Plexus Blockade
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
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 study testing Diaphragmatic excursion evaluation in people with Brachial Plexus Blockade, run by Cairo 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 1 inclusion and 1 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 22 May 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?
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?
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion (time frame: baseline and 30 minutes after the block). 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 NCT06820853, which also lists 7 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 22 May 2025.