Pain, PostoperativeNCT05105282

Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block

A study testing Two different blocks with same local anesthetic volume in people with Pain, Postoperative and Serratus Anterior Plane Block, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain, Postoperative, Serratus Anterior Plane Block, Thoracic Surgery, Video-Assisted
What is being tested?: Two different blocks with same local anesthetic volume
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: 22 Oct 2021to 8 Jun 2022
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

Patient refusing the procedure
History of chronic analgesic therapy
History of local anesthetic allergy
Infection in the intervention area
Patients with bleeding disorders
Emergency surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Ultrasound-Guided Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, in this study, the analgesic efficacy of two different methods, DSAPB and SSAPB, will be compared.

Conditions: Pain, Postoperative, Serratus Anterior Plane Block, Thoracic Surgery, Video-Assisted
Being tested: Two different blocks with same local anesthetic volume
Keywords: Postoperative Pain, Serratus Anterior Plane Block, Video-Assisted Thoracic Surgery, VATS
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Two different blocks with same local anesthetic volumeProcedure or surgery
Deep serratus anterior block and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.

Study groups in NCT05105282
Study group	Role	What they receive
Deep 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: Two different blocks with same local anesthetic volume
Superficial 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 above 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: Two different blocks with same local anesthetic volume

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, 24th and 48th hours after surgery.
Measured: 48 hours after surgery

Secondary outcomes (1)

Morphine Consumption
Morphine consumption for 24 hours will be recorded
Measured: 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 20218 Jun 2022

First posted3 Nov 2021
Study start22 Oct 2021
Primary completion13 Apr 2022
Study completion8 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05105282
Sponsor's protocol ID: E.Kurul-E1-21-2067
Status last verified: Jun 2022
First submitted: 22 Oct 2021
Last updated: 10 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of Ultrasound-Guided Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
ClinicalTrials.gov ID: NCT05105282
Acronym / sponsor ID: E.Kurul-E1-21-2067
Conditions: Pain, Postoperative, Serratus Anterior Plane Block, Thoracic Surgery, Video-Assisted
Keywords: Postoperative Pain, Serratus Anterior Plane Block, Video-Assisted Thoracic Surgery, VATS
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
Study start: 22 Oct 2021 (actual)
Primary completion: 13 Apr 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 3 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Deep Serratus Anterior Plane Block	Active comparator	Procedure: Two different blocks with same local anesthetic volumeFollowing 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.
Superficial Serratus Anterior Plane Block	Active comparator	Procedure: Two different blocks with same local anesthetic volumeFollowing the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above 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.

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 (6 listed)

Patient refusing the procedure
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
Two different blocks with same local anesthetic volumeDeep serratus anterior block and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.	Procedure or surgery	Deep Serratus Anterior Plane Block, Superficial Serratus Anterior Plane Block

Primary outcome

Pain Scores
Time frame: 48 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, 24th and 48th hours after surgery.

1 secondary outcome

Morphine Consumption
Time frame: 24 hours after surgery

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 10 Jun 2022.

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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?

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 6 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 10 Jun 2022. 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?

Pain Scores (time frame: 48 hours after surgery). 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 NCT05105282.

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 10 Jun 2022.