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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061667
• Other study ID #: 2021.066.IRB1.022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2021
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 15, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Thoracic Paravertebral Block
Paravertebral block for postoperative analgesia in thoracic surgery
• Rhomboid Block
Rhomboid block for postoperative analgesia in thoracic surgery

Locations

Country	Name	City	State
Turkey	Koç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Çiftçi 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. — View Citation

Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agrò 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. — View Citation

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. Erratum in: J Clin Anesth. 2020 Aug;63:109789. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of nausea and vomiting	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.	24 hours
Secondary	Patient satisfaction	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.	24 hours