The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Acute Pain; Body Mass Index; Thoracic Surgery, Video-Assisted; Thoracic Paravertebral Block
• Intervention / Treatment: Procedure: Thoracic Paravertebral Block

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Keçiören, Ankara, Turkey, 06290
      • Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
    • Çankaya, Ankara, Turkey, 06290
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with a BMI of 18-24.9 kg/m2; The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.	Procedure: Thoracic Paravertebral Block; Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
Active Comparator: Patients with a BMI of 25-29.9 kg/m2; The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.	Procedure: Thoracic Paravertebral Block; Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
Active Comparator: Patients with a BMI of 30-40 kg/m2; The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.	Procedure: Thoracic Paravertebral Block; Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Consumption	Morphine consumption for 24 hours will be recorded	24 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Nilgün ZENGİN, MD, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 13, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Aneurysm; Pain, Postoperative; Acute Pain; Aneurysm, Dissecting
• Other Study ID Numbers: E.Kurul-E1-22-2596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No