NCT05105282

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, 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.

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 Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

October 22, 2021

Last Update Submit

June 8, 2022

Conditions

Keywords

Postoperative PainSerratus Anterior Plane BlockVideo-Assisted Thoracic SurgeryVATS

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.

    48 hours after surgery

Secondary Outcomes (1)

  • Morphine Consumption

    24 hours after surgery

Study Arms (2)

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.

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.

Procedure: Two different blocks with same local anesthetic volume

Interventions

Deep serratus anterior block and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.

Deep Serratus Anterior Plane BlockSuperficial Serratus Anterior Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Patients with bleeding disorders
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

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

October 22, 2021

First Posted

November 3, 2021

Study Start

October 22, 2021

Primary Completion

April 13, 2022

Study Completion

June 8, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations