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

NCT05061667 | Completed

• 1 other identifier: 2021.066.IRB1.022
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

Thoracic surgery; Postoperative pain; Rhomboid block; Paravertebral block

Outcome Measures

Primary Outcomes (2)

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

  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.

  24 hours

• Difference in additional analgesic usage between two groups

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

  24 hours

Secondary Outcomes (2)

• Incidence of nausea and vomiting

  24 hours

• Patient satisfaction

  24 hours

Study Arms (2)

Group I

ACTIVE COMPARATOR

Group I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).

Procedure: Thoracic Paravertebral Block

Group II

EXPERIMENTAL

Group II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).

Procedure: Rhomboid Block

Interventions

Thoracic Paravertebral Block PROCEDURE

Paravertebral block for postoperative analgesia in thoracic surgery

Also known as: TPVB

Group I

Rhomboid Block PROCEDURE

Rhomboid block for postoperative analgesia in thoracic surgery

Group II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (3)

• Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.

  PMID: 33198430 BACKGROUND

• Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.

  PMID: 32470838 BACKGROUND

• Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available.

  PMID: 31668692 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: September 29, 2021
• Study Start: January 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 15, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the publication
• Access Criteria: Academic purposes

Locations

TU (1)