Clavicle FractureNCT06269562
SPSIPB and CPB on Clavicle Surgeries
A study testing Serratus posterior superior intercostal plane block and clavipectoral plane block in people with Clavicle Fracture and Postoperative Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture, Postoperative Pain, Analgesia
- What is being tested?
- Serratus posterior superior intercostal plane block and clavipectoral plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 4 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study
Who cannot join
- patients with bleeding disorders
- patients with signs of infection in the block application area
- patients with unstable haemodynamics
- patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
- patients with vascular disease,
- patients with respiratory distress
- patients whose consent for the study could not be obtained or who did not accept to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Efficacy of Clavipectoral Plan Block and Serratus Posterior Superior Intercostal Plane Block Combination in Clavicle Surgeries: A Report of Five Cases
Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).
- Conditions
- Clavicle Fracture, Postoperative Pain, Analgesia
- Being tested
- Serratus posterior superior intercostal plane block and clavipectoral plane block
- Keywords
- serratus posterior superior intercostal plane block, clavipectoral plane block, clavicle fracture, pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane block and clavipectoral plane blockProcedure or surgery
The analgesic effectiveness achieved by the concurrent application of these two techniques was investigated.
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | consists of 5 patients in whom both techniques were applied Receives: Procedure: Serratus posterior superior intercostal plane block and clavipectoral plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
0=no pain , 10= the worst pain
Measured: 24 hours after the procedure
Secondary outcomes (1)
tramadol consumption
total tramadol consumption of patients
Measured: 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Jun 2023
- Primary completion20 Dec 2023
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Balci, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269562
- Sponsor's protocol ID
- clavicle
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Clavipectoral Plan Block and Serratus Posterior Superior Intercostal Plane Block Combination in Clavicle Surgeries: A Report of Five Cases
- ClinicalTrials.gov ID
- NCT06269562
- Acronym / sponsor ID
- clavicle
- Conditions
- Clavicle Fracture, Postoperative Pain, Analgesia
- Keywords
- serratus posterior superior intercostal plane block, clavipectoral plane block, clavicle fracture, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 21 Feb 2024 (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.
Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Procedure: Serratus posterior superior intercostal plane block and clavipectoral plane blockconsists of 5 patients in whom both techniques were applied |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study
Key exclusion criteria (7 listed)
- patients with bleeding disorders
- patients with signs of infection in the block application area
- patients with unstable haemodynamics
- patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
- patients with vascular 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 |
|---|---|---|
| Serratus posterior superior intercostal plane block and clavipectoral plane blockThe analgesic effectiveness achieved by the concurrent application of these two techniques was investigated. | Procedure or surgery | Block |
Primary outcome
Numerical Rating Scale
Time frame: 24 hours after the procedure
0=no pain , 10= the worst pain
1 secondary outcome
tramadol consumption
Time frame: 24 hours after the procedure
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 21 Feb 2024.
- Individual participant dataSharing planned: No
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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 study testing Serratus posterior superior intercostal plane block and clavipectoral plane block in people with Clavicle Fracture and Postoperative Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 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 21 Feb 2024. 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 Turkey (Türkiye). 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?
Numerical Rating Scale (time frame: 24 hours after the procedure). 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 21 Feb 2024.