Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

NCT ID: NCT05427955

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-02-03

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 is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

One-level Erector Spinae Plane Block

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.

Group Type: ACTIVE_COMPARATOR

One-level Erector Spinae Plane Block

Intervention Type: PROCEDURE

One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.

Bi-level Erector Spinae Plane Block

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T4 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T6 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

Group Type: ACTIVE_COMPARATOR

Bi-level Erector Spinae Plane Block

Intervention Type: PROCEDURE

Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.

Interventions

One-level Erector Spinae Plane Block

One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.

Intervention Type: PROCEDURE

Bi-level Erector Spinae Plane Block

Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years
• American Society of Anesthesiologists physical status I-II-III
• Body mass index between 18-40 kg/m2
• Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Nilgün Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.

Reference Type: DERIVED

PMID: 39103782 (View on PubMed)

Zengin EN, Zengin M, Yigit H, Sazak H, Sekerci S, Alagoz A. Comparison of the effects of one-level and bi-level pre-incisional erector spinae plane block on postoperative acute pain in video-assisted thoracoscopic surgery; a prospective, randomized, double-blind trial. BMC Anesthesiol. 2023 Aug 11;23(1):270. doi: 10.1186/s12871-023-02232-8.

Reference Type: DERIVED

PMID: 37568076 (View on PubMed)

Other Identifiers

E.Kurul-E1-22-2534

Identifier Type: -

Identifier Source: org_study_id