The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

Pain, Postoperative Clinical Trial

Official title:

The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357976
• Other study ID #: E.Kurul-E1-22-2596
• Status: Completed
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: May 13, 2023

Study information

• Verified date: May 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity has become one of the world's leading health problems. It is known that obesity causes many diseases and negatively affects the quality of life. For this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. One of them is postoperative pain. Although there are studies stating that there is no relationship between body mass index (BMI) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. There are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in BMI.

After thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study will compare the effects of BMI on postoperative pain in patients undergoing TPVB for postoperative analgesia and thoracoscopic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 13, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 to 80 years old

• ASA physical status I-II-III

• BMI 18 to 40 kg/m2

• Elective video-assisted thoracoscopic surgery

Exclusion Criteria:

• Patient refusing the procedure

• Emergency surgery

• Chronic opioid or analgesic use

• Patients who will operate under emergency conditions

• Patients who will not undergo VATS

Related Conditions & MeSH terms

• Acute Pain
• Aortic Dissection
• Body Mass Index
• Pain, Postoperative
• Thoracic Paravertebral Block
• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• Thoracic Paravertebral Block
Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	Ankara
Turkey	Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital	Keçiören	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours after surgery.	1st hour after surgery.
Primary	Pain Scores	Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	2nd-hour after surgery.
Primary	Pain Scores	Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	4th-hour after surgery.
Primary	Pain Scores	Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	12th-hour after surgery.
Primary	Pain Scores	Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	24th-hour after surgery.
Primary	Pain Scores	Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	48th-hour after surgery.
Secondary	Morphine Consumption	Morphine consumption for 24 hours will be recorded	24 hours after surgery