TPVB or SPSIPB in Pain Management After VATS

Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Regional Anesthesia Morbidity; Video-assisted Thoracoscopic Surgery; Paravertebral Block; Serratus Posterior Superior Intercostal Plane Block
• Intervention / Treatment: Procedure: Serratus Posterior Superior Intercostal Plane Block; Procedure: Paravertebral Block

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamil Darçın, MD; Phone Number: +90 505 589 50 99; Email: drdarcink@gmail.com
• Study Contact Backup: Name: Yasemin Sincer, MD; Phone Number: +90 531 204 08 34; Email: sincer.yasemin@gmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Recruiting
    • Koc University
    • Contact: Kamil Darçın; Phone Number: +905055895099; Email: kdarcin@ku.edu.tr
    • Contact: Yasemin Sincer; Phone Number: +90512040834; Email: sincer.yasemin@gmail.com
    • Principal Investigator: Kamil Darçın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; 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; 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.
Active Comparator: Group P; Participants who will be receiving a thoracal paravertebral block with a single dose of 30 ml of %0,25 bupivacaine	Procedure: Paravertebral Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	24 hours post-surgery

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Principal Investigator: Kamil Darçın, MD, Koc University

Study record dates

Study Major Dates

• Study Start (Estimated): January 3, 2025
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: paravertebral block; video-assisted thoracoscopic surgery; serratus posterior superior intercostal plane block
• Other Study ID Numbers: 2024.174.IRB1.019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting from 6 months after publication for 5 years
• IPD Sharing Access Criteria: no access criteria
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No