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NCT Number: NCT06426706

TPVB or SPSIPB in Pain Management After VATS

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total opioid consumption

    Time frame: 24 hours post-surgery

    all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage

Secondary outcomes

  1. Numeric rating scale scores for pain

    Time frame: 24 hours post-surgery

    the scale between 0: no pain and 10:highes pain answered by the participants

  2. Opioid related side effects

    Time frame: 24 hours post-surgery

    Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions

Study contacts

Contact information is provided by the study sponsor or research team.

Kamil Darçın, MD

CONTACT

[email protected]

+90 505 589 50 99

Yasemin Sincer, MD

CONTACT

[email protected]

+90 531 204 08 34

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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