Serratus Plane BlockNCT04293354
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
A study testing Serratus Plane Block in people with Serratus Plane Block, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Serratus Plane Block
- What is being tested?
- Serratus Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2017to 1 Apr 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III
Who cannot join
- Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Hospital
Kahramanmaraş
About this study
Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic.
Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.
Read the detailed description
After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed envelope method. The patients were divided into two groups as the SAPB-performed group (Group S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device prepared with tramadol was applied to all patients.
- Conditions
- Serratus Plane Block
- Being tested
- Serratus Plane Block, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Plane BlockProcedure or surgery
Serratus Plane Block was performed
ControlProcedure or surgery
No block was performed
| Study group | Role | What they receive |
|---|---|---|
| Serratus Plane Block | Active comparator | The Serratus plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. Receives: Procedure: Serratus Plane Block |
| Control | Sham comparator | No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Tramadol
Measured: up to 24 hour
Secondary outcomes (1)
Numerical Rating Scale (NRS)
pain scores
Measured: at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Aug 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serratus Plane BlockStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözen Öksüz, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293354
- Sponsor's protocol ID
- 2017/11-18
- Status last verified
- Feb 2020
- First submitted
- 29 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
PubMed 28447227Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.
PubMed 33383266
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
- ClinicalTrials.gov ID
- NCT04293354
- Acronym / sponsor ID
- 2017/11-18
- Conditions
- Serratus Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 3 Mar 2020 (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.
Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic.
Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.
Detailed description
After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed envelope method. The patients were divided into two groups as the SAPB-performed group (Group S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device prepared with tramadol was applied to all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Plane Block | Active comparator | Procedure: Serratus Plane BlockThe Serratus plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. |
| Control | Sham comparator | Procedure: ControlNo block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III
Key exclusion criteria (1 listed)
- Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure
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 Plane BlockSerratus Plane Block was performed | Procedure or surgery | Serratus Plane Block |
| ControlNo block was performed | Procedure or surgery | Control |
Primary outcome
Analgesic consumption
Time frame: up to 24 hour
Tramadol
1 secondary outcome
Numerical Rating Scale (NRS)
Time frame: at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
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 3 Mar 2020.
- Background: PubMed 28447227Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
- Derived from this study: PubMed 33383266Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.
- Individual participant dataSharing planned: Undecided
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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 Plane Block in people with Serratus Plane Block, run by Kahramanmaras Sutcu Imam 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 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 3 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Analgesic consumption (time frame: up to 24 hour). 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 NCT04293354, which also lists 2 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 3 Mar 2020.