NCT05427955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

June 16, 2022

Last Update Submit

February 5, 2023

Conditions

Pain, PostoperativeThoracic Surgery, Video-AssistedErector Spinae Plane BlockMultimodal Analgesia

Outcome Measures

Primary Outcomes (6)

  • Pain scores

    Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    1st hour after surgery

  • Pain scores

    Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    2nd-hour after surgery.

  • Pain scores

    Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    4th-hour after surgery.

  • Pain scores

    Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    12th-hour after surgery.

  • Pain scores

    Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    24th-hour after surgery.

  • Pain scores

    Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

    48th-hour after surgery.

Secondary Outcomes (1)

  • Morphine Consumption

    24 hours after surgery

Study Arms (2)

One-level Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: One-level Erector Spinae Plane Block

Bi-level Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Bi-level Erector Spinae Plane Block

Interventions

One-level Erector Spinae Plane BlockPROCEDURE

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.

One-level Erector Spinae Plane Block
Bi-level Erector Spinae Plane BlockPROCEDURE

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.

Bi-level Erector Spinae Plane Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara City Hospital

Çankaya, Ankara, 06290, Turkey (Türkiye)

Location

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Keçiören, Ankara, 06290, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 39103782DERIVED

  • 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.

    PMID: 37568076DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns 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

June 16, 2022

First Posted

June 22, 2022

Study Start

April 20, 2022

Primary Completion

December 25, 2022

Study Completion

February 3, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

TU(2)