NCT05852561

Brief Summary

Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen. The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.

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 May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

May 2, 2023

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    first 24 hours

Secondary Outcomes (1)

  • Visual analog pain score

    first 48 hours

Study Arms (2)

Group Superficial+Deep Serratus Anterior Plan Block

ACTIVE COMPARATOR

Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery

Other: Group Superficial+Deep Serratus Anterior Plan Block

Group Deep Serratus Anterior Plan Block

ACTIVE COMPARATOR

Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery

Other: Group Deep Serratus Anterior Plan Block

Interventions

The block will be performed after induction of general anesthesia and surgical positioning. 15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles. The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle.

Group Superficial+Deep Serratus Anterior Plan Block

30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle.

Group Deep Serratus Anterior Plan Block

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • To undergo Video Assisted Thoracic Surgery
  • Being between the ages of 18-65 years

You may not qualify if:

  • having a known heart, kidney, liver or hematological disease
  • having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
  • Routine analgesic use and history of analgesic use in the last 24 hours
  • Not willingto participate in the study
  • Uncooperative patients who have coagulopathy or use anticoagulant drugs
  • To be allergic to one of the drugs to be used
  • Contraindication for Video Assisted Thoracic Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Ahiskalioglu

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.

    PMID: 31045789BACKGROUND
  • Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.

    PMID: 33546068BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Oral Ahiskalioglu

    Ataturk University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

May 15, 2023

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations