TPVB or SPSIPB in Pain Management After VATS

NCT ID: NCT06426706

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2025-03-15

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Serratus Posterior Superior Intercostal Plane Block

Intervention Type: 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 P

Participants who will be receiving a thoracal paravertebral block with a single dose of 30 ml of %0,25 bupivacaine

Group Type: ACTIVE_COMPARATOR

Paravertebral Block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Kamil Darcin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamil Darçın, MD

Role: PRINCIPAL_INVESTIGATOR

Koç University

Locations

Koc University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Kamil Darçın, MD

Role: CONTACT

drdarcink@gmail.com

+90 505 589 50 99

Yasemin Sincer, MD

Role: CONTACT

sincer.yasemin@gmail.com

+90 531 204 08 34

Facility Contacts

Kamil Darçın

Role: primary

kdarcin@ku.edu.tr

+905055895099

Yasemin Sincer

Role: backup

sincer.yasemin@gmail.com

+90512040834

Other Identifiers

2024.174.IRB1.019

Identifier Type: -

Identifier Source: org_study_id