Pain, PostoperativeNCT03496727
Serratus Anterior Block for Video-assisted Thoracoscopic Surgery
An observational study of Pain, Postoperative, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Serratus anterior plane block
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Mar 2018
- 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 80 years
- All sexes
- Adult, Older adult
Study population: VATS ( Video-assisted thoracoscopy)
Who may be able to join
- VATS( Video-assisted thoracoscopy) operation
- a.Serratus anterior plane block b.patient controlled analgesia
Who cannot join
- missing data written consent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kahramanmaras Sutcu Imam University Hospital
Kahramanmaraş
KahramanmarasSIU
Kahramanmaraş
About this study
Official title: Analgesic Effectiveness of Serratus Anterior Block for Video-assisted Thoracoscopic Surgery
Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. The serratus plane block is used in our clinic for postoperative analgesia in VATS operations. The aim of this study was to evaluate the postoperative pain scores and use of analgesia in patients performed with the serratus plane block in VATS operations in a
1-year period.
Read the detailed description
Approval for the study was granted by the Clinical Research Ethics Committee and all procedures were carried out in accordance with the Helsinki Declaration. A retrospective examination was made of the anesthesia forms of patients underwent VATS May 2016 and June 2017. Due to incomplete data of 1 of these 35 patients, that case was excluded from the study. The patients were divided into two groups. 24 patients were performed SAPB and iv PCA (intravenous patient controlled analgesia) and 10 patient's pain management were provided with only PCA. No block was administered to 10 patients because of anticoagulant therapy and patient refused block application. The demographic data of the patients (age, gender, operation type, and duration) were obtained from the anesthesia forms. The postoperative pain scores of the patients, evaluated with a visual analog scale (VAS) at 1, 6, 12 and 24 hours postoperatively and the postoperative doses of analgesia used were taken from the block pain follow-up forms
- Conditions
- Pain, Postoperative
- Being tested
- Serratus anterior plane block, Patient controlled analgesia
- Keywords
- pain, VATS
- 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.
Serratus anterior plane blockProcedure or surgery
Serratus anterior plane block+patient controlled analgesia
Patient controlled analgesiaProcedure or surgery
Patient-controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block | Anesthesia induction was performed to all patients. At the end of the operation, 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 | |
| Patient controlled analgesia | Anesthesia induction was performed on all patients.At the end of the operation, all patients were performed with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. Receives: Procedure: Patient controlled analgesia |
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)
Post-operative pain scores
The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS) 1.,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 posted12 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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
- 35 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
- NCT03496727
- Sponsor's protocol ID
- 2018/01-29
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
PubMed 29033355
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effectiveness of Serratus Anterior Block for Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03496727
- Acronym / sponsor ID
- 2018/01-29
- Conditions
- Pain, Postoperative
- Keywords
- pain, VATS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 12 Apr 2018 (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.
Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. The serratus plane block is used in our clinic for postoperative analgesia in VATS operations. The aim of this study was to evaluate the postoperative pain scores and use of analgesia in patients performed with the serratus plane block in VATS operations in a
1-year period.
Detailed description
Approval for the study was granted by the Clinical Research Ethics Committee and all procedures were carried out in accordance with the Helsinki Declaration. A retrospective examination was made of the anesthesia forms of patients underwent VATS May 2016 and June 2017. Due to incomplete data of 1 of these 35 patients, that case was excluded from the study. The patients were divided into two groups. 24 patients were performed SAPB and iv PCA (intravenous patient controlled analgesia) and 10 patient's pain management were provided with only PCA. No block was administered to 10 patients because of anticoagulant therapy and patient refused block application. The demographic data of the patients (age, gender, operation type, and duration) were obtained from the anesthesia forms. The postoperative pain scores of the patients, evaluated with a visual analog scale (VAS) at 1, 6, 12 and 24 hours postoperatively and the postoperative doses of analgesia used were taken from the block pain follow-up forms
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block | – | Procedure: Serratus anterior plane blockAnesthesia induction was performed to all patients. At the end of the operation, 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. |
| Patient controlled analgesia | – | Procedure: Patient controlled analgesiaAnesthesia induction was performed on all patients.At the end of the operation, all patients were performed with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- VATS ( Video-assisted thoracoscopy)
Key inclusion criteria (2 listed)
- VATS( Video-assisted thoracoscopy) operation
- a.Serratus anterior plane block b.patient controlled analgesia
Key exclusion criteria (1 listed)
- missing data written consent
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 anterior plane blockSerratus anterior plane block+patient controlled analgesia | Procedure or surgery | Serratus anterior plane block |
| Patient controlled analgesiaPatient-controlled analgesia | Procedure or surgery | Patient controlled analgesia |
Primary outcome
Postoperative analgesic consumption
Time frame: up to 24 hour
Postoperative analgesic consumption
1 secondary outcome
Post-operative pain scores
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 13 Apr 2018.
- Background: PubMed 29033355Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
2 sites 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 2 sites 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 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 NCT03496727, 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 13 Apr 2018.