NCT06073197

Brief Summary

Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery. Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery. Interventions: Preoperative SAPB or ESPB implementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

Study Start

First participant enrolled

July 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

September 19, 2023

Last Update Submit

October 3, 2023

Conditions

AnalgesiaPain, PostoperativeThoracicAnesthesia

Keywords

serratus anterior plane blockvideo-assisted thoracoscopic surgeryerector spinae blockpostoperative analgesia

Outcome Measures

Primary Outcomes (2)

  • postoperative analgesic effects

    The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10).

    first 48 hours

  • intraoperative analgesic effects

    The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups.

    intraoperative phase

Secondary Outcomes (4)

  • side effects

    first 48 hours

  • complications

    first 48 hours

  • mobilization

    first 48 hours

  • stay of hospital

    first 4 days

Study Arms (2)

erector spinae plane block

ACTIVE COMPARATOR

Plane blocks implemented on preoperative course on 35 patients for group.

Procedure: erector spinae plane block

combined deep and superficial serratus anterior plane block

ACTIVE COMPARATOR

Plane blocks implemented on preoperative course on 35 patients for group.

Procedure: combined deep and superficial serratus anterior plane block

Interventions

erector spinae plane blockPROCEDURE

Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.

erector spinae plane block
combined deep and superficial serratus anterior plane blockPROCEDURE

Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.

combined deep and superficial serratus anterior plane block

Eligibility Criteria

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

You may qualify if:

  • American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS

You may not qualify if:

  • Patients who did not give consent
  • Local anaesthetic allergy
  • Known or suspected coagulopathy
  • İnfection at the injection site
  • History of thoracic surgery
  • Severe cardiovascular disease
  • Hepatic or renal insufficiency (glomerular filtration rate \<15 ml/min/1.73 m2)
  • Severe neurological or psychiatric disorders
  • Chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • seda cansabuncu

    Uludag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized, controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 10, 2023

Study Start

July 2, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

TU(1)