Postoperative PainNCT05160961
US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS
A study testing Serratus anterior plane block and Erector spinae plane block in people with Postoperative Pain and Video-Assisted Thoracoscopic Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Serratus Anterior Plane Block
- What is being tested?
- Serratus anterior plane block and Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2021to 15 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-30 kg/m2
- Patients undergoing elective video assiste thoracoscopic surgery
Who cannot join
- Advanced cancer
- History of chronic analgesic therapy
- History of local anesthetic allergy
- Infection in the intervention area
- Patients with bleeding disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
Musa Zengin, MD, +903125677233, musazengin@gmail.com
About this study
Official title: Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.
Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.
- Conditions
- Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Serratus Anterior Plane Block, Erector Spinae Plane Block, Acute Pain, Chronic Pain
- Being tested
- Serratus anterior plane block, Erector spinae plane block
- Keywords
- Serratus anterior plane block, Erector spinae plane block, Acute Pain, Chronic Pain
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic 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
Also called Drug
Serratus anterior plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
Erector spinae plane blockProcedure or surgery
Also called Drug
Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plane Block | Active comparator | Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. Receives: Procedure: Serratus anterior plane block |
| Erector spinae plane block | Active comparator | After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
Measured: First 24 hours after surgery
Secondary outcomes (1)
Chronic pain
Chronic pain findings will be evaluated in the 3rd month and 6th month after surgery by using visual analog from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, or electric shock-like pain; tingling, numbness, or a "pins and needles" feeling, hyperalgesia, allodynia and hypoesthesia) will also be asked to the participants in the 3rd month and 6th month after surgery.
Measured: 3rd month and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start3 Dec 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Musa Zengin, MD, Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160961
- Sponsor's protocol ID
- E.Kurul-E1-21-2142
- Status last verified
- Aug 2023
- First submitted
- 3 Dec 2021
- Last updated
- 29 Aug 2023
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.
- ClinicalTrials.gov ID
- NCT05160961
- Acronym / sponsor ID
- E.Kurul-E1-21-2142
- Conditions
- Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Serratus Anterior Plane Block, Erector Spinae Plane Block, Acute Pain, Chronic Pain
- Keywords
- Serratus anterior plane block, Erector spinae plane block, Acute Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 16 Dec 2021 (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.
Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Anterior Plane Block | Active comparator | Procedure: Serratus anterior plane blockFollowing the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane blockAfter the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-30 kg/m2
- Patients undergoing elective video assiste thoracoscopic surgery
Key exclusion criteria (5 listed)
- Advanced cancer
- History of chronic analgesic therapy
- History of local anesthetic allergy
- Infection in the intervention area
- Patients with bleeding disorders
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 blockAlso: DrugSerratus anterior plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position. | Procedure or surgery | Serratus Anterior Plane Block |
| Erector spinae plane blockAlso: DrugErector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position. | Procedure or surgery | Erector spinae plane block |
Primary outcome
Pain scores
Time frame: First 24 hours after surgery
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
1 secondary outcome
Chronic pain
Time frame: 3rd month and 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- 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.
Musa Zengin, MD principal investigator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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 anterior plane block and Erector spinae plane block in people with Postoperative Pain and Video-Assisted Thoracoscopic Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musa Zengin, MD (903125677233, musazengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: First 24 hours after surgery). 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 29 Aug 2023.