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Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block

Primary Purpose

Analgesia, Pain, Postoperative, Thoracic

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

erector spinae plane block

combined deep and superficial serratus anterior plane block

About this trial

This is an interventional other trial for Analgesia focused on measuring serratus anterior plane block, video-assisted thoracoscopic surgery, erector spinae block, postoperative analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS Exclusion Criteria: 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

Sites / Locations

Bursa Uludag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

erector spinae plane block

combined deep and superficial serratus anterior plane block

Arm Description

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

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

side effects

The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present.

complications

The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block.

mobilization

The secondary aim was to compare the mobilization time

stay of hospital

length of stay in the recovery unit and hospital

Full Information

NCT ID

NCT06073197

First Posted

September 19, 2023

Last Updated

October 3, 2023

Sponsor

Uludag University

1. Study Identification

Unique Protocol Identification Number

NCT06073197

Brief Title

Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block

Official Title

Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 2, 2020 (Actual)

Primary Completion Date

February 25, 2021 (Actual)

Study Completion Date

February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Pain, Postoperative, Thoracic, Anesthesia

Keywords

serratus anterior plane block, video-assisted thoracoscopic surgery, erector spinae block, postoperative analgesia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized, controlled

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

erector spinae plane block

Arm Type

Active Comparator

Arm Description

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

Arm Title

combined deep and superficial serratus anterior plane block

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

erector spinae plane block

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

combined deep and superficial serratus anterior plane block

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative analgesic effects

Description

Time Frame

first 48 hours

Title

intraoperative analgesic effects

Description

Time Frame

intraoperative phase

Secondary Outcome Measure Information:

Title

side effects

Description

The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present.

Time Frame

first 48 hours

Title

complications

Description

The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block.

Time Frame

first 48 hours

Title

mobilization

Description

The secondary aim was to compare the mobilization time

Time Frame

first 48 hours

Title

stay of hospital

Description

length of stay in the recovery unit and hospital

Time Frame

first 4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

seda cansabuncu

Organizational Affiliation

Uludag University

Official's Role

Study Chair

Facility Information:

Facility Name

Bursa Uludag University

City

Bursa

Country

Turkey

12. IPD Sharing Statement

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Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block

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