Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block

NCT05121727 | Completed

• 1 other identifier: E.Kurul-E1-21-1862
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 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. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated.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. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB , as in the multimodal analgesia method. This study seeks to evaluate the effect of ESPB and combined DSAPB-SSAPB pain after VATS.

Conditions

Pain, Postoperative; Thoracic Surgery, Video-Assisted; Erector Spinae Plane Block; Serratus Anterior Plane Block; Multimodal Analgesia

Outcome Measures

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, 24th and 48th hours after surgery.

  1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery

Secondary Outcomes (1)

• Morphine Consumption

  24 hours after surgery

Study Arms (2)

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.

Procedure: Erector Spinae Plane Block

Deep and Superficial Serratus Anterior Plane Block

ACTIVE COMPARATOR

In patients who are planned to have combined deep and superficial 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, 10 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anteror area to superficial serratus anteror area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 10 ml of 0.25% bupivacaine will be injected for superficial serratus anetrior block into the interfacial area.

Procedure: Deep and Superficial Serratus Anterior Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

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. 20 ml of 0.25% bupivacaine will be used in applications.

Erector Spinae Plane Block

Deep and Superficial Serratus Anterior Plane Block PROCEDURE

Combined Deep and Superficial 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. 20 ml of 0.25% bupivacaine will be used in applications.

Deep and Superficial Serratus Anterior Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusing the procedure
• History of chronic analgesic or opioid therapy
• History of local anesthetic allergy
• Infection in the intervention area
• Emergency surgery

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• Oostvogels L, Weibel S, Meissner M, Kranke P, Meyer-Friessem CH, Pogatzki-Zahn E, Schnabel A. Erector spinae plane block for postoperative pain. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD013763. doi: 10.1002/14651858.CD013763.pub3.

  PMID: 38345071 DERIVED

• Schnabel A, Weibel S, Pogatzki-Zahn E, Meyer-Friessem CH, Oostvogels L. Erector spinae plane block for postoperative pain. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013763. doi: 10.1002/14651858.CD013763.pub2.

  PMID: 37811665 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 16, 2021
• Study Start: June 6, 2021
• Primary Completion: November 22, 2021
• Study Completion: December 1, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

TU (1)