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Completed

NCT Number: NCT05061667

Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries

The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, 34010, Turkey (Türkiye)

About this study

Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for general thoracic surgery
  • ASA I-III

Exclusion criteria

  • Patients without consent
  • Emergency surgeries
  • Pregnancy
  • Coagulopathies and bleeding diathesis
  • Allergy to local anesthetics
  • Local skin infection at the puncture site

Treatment and study plan

Thoracic Paravertebral Block

Procedure

Paravertebral block for postoperative analgesia in thoracic surgery

Other names: TPVB

Rhomboid Block

Procedure

Rhomboid block for postoperative analgesia in thoracic surgery

Primary outcomes

  1. Difference in Visual Analogue Scale (VAS) scores between two groups

    Time frame: 24 hours

    Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.

  2. Difference in additional analgesic usage between two groups

    Time frame: 24 hours

    Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.

Secondary outcomes

  1. Incidence of nausea and vomiting

    Time frame: 24 hours

    Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours. On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.

  2. Patient satisfaction

    Time frame: 24 hours

    Patient will be reevaluated at 24th hour for analgesic satisfaction. On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2021
Registry last updated
Jan 20, 2022

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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