ClinicalTrials.gg
Status unknownNCT05160961Updated Aug 29, 2023

US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS

An interventional study of Serratus anterior plane block and Erector spinae plane block in Postoperative Pain, Video-Assisted Thoracoscopic Surgery and Serratus Anterior Plane Block, sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital is the lead sponsor of 29 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Advanced cancer
  • History of chronic analgesic therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Patients with bleeding disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Serratus Anterior Plane Block

    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.

    Procedure: Serratus anterior plane block

  • Active comparator
    Erector spinae plane block

    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.

    Procedure: Erector spinae plane block

Interventions

  • ProcedureSerratus anterior plane block

    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.

    Also known as: Drug

  • ProcedureErector spinae plane block

    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.

    Also known as: Drug

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 3rd month and 6th month

07

Study locations

1 of 1 sites recruiting
  • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
    Keçiören, Ankara 06000, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Jun 2024, 30 months after the start.

Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 30 months is above that.

Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2021
First posted
Dec 16, 2021
StartActual
Dec 3, 2021
Primary completionEst.
Jun 15, 2024
CompletionEst.
Jul 15, 2024
Last update
Aug 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160961
Lead sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Musa Zengin (Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital) — Principal investigator
First posted
Dec 16, 2021
Start date
Dec 3, 2021
Primary completion
Jun 15, 2024 (estimated)
Completion
Jul 15, 2024 (estimated)
Last update
Aug 29, 2023

Study contacts

Musa Zengin, MD
Contact
musazengin@gmail.com
903125677233
Ali Alagoz, Assoc Prof
Contact
mdalagoz@gmail.com
+903125677232
Musa Zengin, MD
principal investigator · Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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