Pain, PostoperativeNCT03309267
Serratus Anterior Plane Block Versus Intercostal Block
An observational study of Pain, Postoperative, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intercostal block and Serratus anterior plane block
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2017to 3 Nov 2017
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Thoracotomy Operation
Who may be able to join
- Thoracotomy operation
- a.Serratus anaterior plane block b.Intercostal block
Who cannot join
- missing data
- written consent
- rethoracotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Anterior Plane Block Versus Intercostal Block For Postoperative Analgesia Following Thoracotomy
Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications.
we aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and analgesic consumption in patients undergoing thoracotomy operation.
Read the detailed description
Patients who underwent thoracotomy operation in our hospital between May 2016 and June 2017 were examined. A retrospective evaluation was made of the data that was retrieved from the records of a total of 49 patients aged 18-75 years, ASA I-III, who were applied with Intercostal (IB) or Serratus anterior plane(SAPB) for a thoracotomy operation. The patient information was retrieved from the patient records and anesthesia block forms. The data were examined in respect of age, sex, height, weight, ASA, operation type, operating time, the amount of postoperative analgesic consumption, VAS at 1.,2.,4.,6.,12.,24. hours and complications (atelectasis, nausea, vomiting, hypotension and bradycardia).
Statistical analysis was performed using the SPSS program for Mac, version 17.0 (SPSS,Chicago,IL). Descriptive statistics are presented as mean and SD, and as the number of cases (n) and the corresponding percentage (%) for nominal variables. T tests were performed for normally continuous variables. The Mann-Whitney U test was used for non-parametric variables. A value of p < 0.05 was considered statistically significant.
- Conditions
- Pain, Postoperative
- Being tested
- Intercostal block, Serratus anterior plane block
- Keywords
- pain, thoracotomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal blockProcedure or surgery
Intercostal block +patient controlled analgesia
Serratus anterior plane blockProcedure or surgery
Serratus anterior plane block+patient controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| Intercostal block | Anesthesia induction was performed to all patients .At the end of the operation some patients were performed with intercostal block by the chest surgeon. For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. Receives: Procedure: Intercostal block | |
| Serratus anterior plane block | Anesthesia induction was performed to all patients. At the end of the operation some patients were performed SAPB under Ultrasound guidance by the same anesthetist.For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. Receives: Procedure: Serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic consumption
Postoperative analgesic consumption
Measured: up to 24 hour
Secondary outcomes (1)
Visuel analog scala (VAS)
1.,2.,4.,6.,12.,24. hour
Measured: up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start6 Oct 2017
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 42 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
- Investigators
- Gözen Öksüz, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309267
- Sponsor's protocol ID
- 2017/14-18
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28447227
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block Versus Intercostal Block For Postoperative Analgesia Following Thoracotomy
- ClinicalTrials.gov ID
- NCT03309267
- Acronym / sponsor ID
- 2017/14-18
- Conditions
- Pain, Postoperative
- Keywords
- pain, thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 13 Oct 2017 (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.
Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications.
we aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and analgesic consumption in patients undergoing thoracotomy operation.
Detailed description
Patients who underwent thoracotomy operation in our hospital between May 2016 and June 2017 were examined. A retrospective evaluation was made of the data that was retrieved from the records of a total of 49 patients aged 18-75 years, ASA I-III, who were applied with Intercostal (IB) or Serratus anterior plane(SAPB) for a thoracotomy operation. The patient information was retrieved from the patient records and anesthesia block forms. The data were examined in respect of age, sex, height, weight, ASA, operation type, operating time, the amount of postoperative analgesic consumption, VAS at 1.,2.,4.,6.,12.,24. hours and complications (atelectasis, nausea, vomiting, hypotension and bradycardia).
Statistical analysis was performed using the SPSS program for Mac, version 17.0 (SPSS,Chicago,IL). Descriptive statistics are presented as mean and SD, and as the number of cases (n) and the corresponding percentage (%) for nominal variables. T tests were performed for normally continuous variables. The Mann-Whitney U test was used for non-parametric variables. A value of p < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal block | – | Procedure: Intercostal blockAnesthesia induction was performed to all patients .At the end of the operation some patients were performed with intercostal block by the chest surgeon. For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. |
| Serratus anterior plane block | – | Procedure: Serratus anterior plane blockAnesthesia induction was performed to all patients. At the end of the operation some patients were performed SAPB under Ultrasound guidance by the same anesthetist.For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Thoracotomy Operation
Key inclusion criteria (2 listed)
- Thoracotomy operation
- a.Serratus anaterior plane block b.Intercostal block
Key exclusion criteria (3 listed)
- missing data
- written consent
- rethoracotomy
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 |
|---|---|---|
| Intercostal blockIntercostal block +patient controlled analgesia | Procedure or surgery | Intercostal block |
| Serratus anterior plane blockSerratus anterior plane block+patient controlled analgesia | Procedure or surgery | Serratus anterior plane block |
Primary outcome
Postoperative analgesic consumption
Time frame: up to 24 hour
Postoperative analgesic consumption
1 secondary outcome
Visuel analog scala (VAS)
Time frame: up to 24 hour
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 7 Nov 2017.
- 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.
- 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.
Gözen Öksüz principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, 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 2 inclusion and 3 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 7 Nov 2017. 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?
Postoperative 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 NCT03309267, which also lists 1 linked publication.
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 7 Nov 2017.