TPVB or SPSIPB in Pain Management After VATS

NCT06426706 | Recruiting

• 1 other identifier: 2024.174.IRB1.019
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Numeric rating scale scores for pain

  24 hours post-surgery

• Opioid related side effects

  24 hours post-surgery

Study Arms (2)

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

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.

Group S

Paravertebral Block PROCEDURE

Before the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.

Group P

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Study Officials

• Kamil Darçın, MD

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: January 3, 2025
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting from 6 months after publication for 5 years
• Access Criteria: no access criteria

Locations

TU (1)