TPVB or SPSIPB in Pain Management After VATS | NCT06426706

Studies
TPVB or SPSIPB in Pain Management After VATS

NCT06426706

Sponsor

Koç University

Status

Recruiting

Last Update Posted

Jan 3, 2025Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Video-assisted Thoracoscopic Surgery
Paravertebral Block
Serratus Posterior Superior Intercostal Plane Block
Regional Anesthesia Morbidity

Interventions

Serratus Posterior Superior Intercostal Plane Block
Paravertebral Block

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2025Estimated

Primary Completion Date

Feb 15, 2025Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

May 19, 2024

First Submission Date that Met QC Criteria

May 19, 2024

First Posted Date

May 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2025

Last Update Posted Date

Jan 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are:

How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects?

Participants will be divided in two groups:

TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects.

The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively.

Detailed Description

Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.

Conditions Module

Conditions

Video-assisted Thoracoscopic Surgery
Paravertebral Block
Serratus Posterior Superior Intercostal Plane Block
Regional Anesthesia Morbidity

Keywords

video-assisted thoracoscopic surgery
paravertebral block
serratus posterior superior intercostal plane block

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group S	Experimental	Participants who will be receiving a serratus posterior superior intercostal plane block with a single dose of 30 ml of %0,25 bupivacaine	Procedure: Serratus Posterior Superior Intercostal Plane Block
Group P	Active Comparator	Participants who will be receiving a thoracal paravertebral block with a single dose of 30 ml of %0,25 bupivacaine	Procedure: Paravertebral Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serratus Posterior Superior Intercostal Plane Block	Procedure	Before the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total opioid consumption	all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage	24 hours post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Numeric rating scale scores for pain	the scale between 0: no pain and 10:highes pain answered by the participants	24 hours post-surgery
Opioid related side effects	Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery

Exclusion Criteria:

Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kamil Darçın, MD	Contact	+90 505 589 50 99		drdarcink@gmail.com
Yasemin Sincer, MD	Contact	+90 531 204 08 34		sincer.yasemin@gmail.com

Overall Officials

Name	Affiliation	Role
Kamil Darçın, MD	Koç University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koc University	Recruiting	Istanbul		34010	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Starting from 6 months after publication for 5 years

Access Criteria

no access criteria

URL

Not provided