The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

Not Applicable

Completed

• Conditions: Thoracic Paravertebral Block; Acute Pain; Body Mass Index; Pain, Postoperative; Thoracic Surgery, Video-Assisted
• Interventions: Procedure: Thoracic Paravertebral Block

• Registration Number: NCT05357976
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Status Verified: 2023-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-13
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with a BMI of 18-24.9 kg/m2	Thoracic Paravertebral Block	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.
Patients with a BMI of 25-29.9 kg/m2	Thoracic Paravertebral Block	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.
Patients with a BMI of 30-40 kg/m2	Thoracic Paravertebral Block	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.

Primary Outcome Measures

Name	Time	Method
Pain Scores	48th-hour after surgery.	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).

Secondary Outcome Measures

Name	Time	Method
Morphine Consumption	24 hours after surgery	Morphine consumption for 24 hours will be recorded

Trial Locations

Locations (2)

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital; 🇹🇷 Keçiören, Ankara, Turkey

Ankara City Hospital; 🇹🇷 Çankaya, Ankara, Turkey