Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia

Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Thoracotomy; Postoperative Analgesia; Local Anesthetic; Thoracic Paravertebral Block
• Intervention / Treatment: Procedure: TPVB with 20 ml; Procedure: TPVB with 25 ml; Procedure: TPVB with 30 ml

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

Contacts and Locations

• Study Contact: Name: Emine N ZENGİN; Phone Number: +905063370548; Email: nilbavullu@yahoo.com

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey, 06290
      • Recruiting
      • Ankara City Hospital
      • Contact: Emine N Zengin, MD; Phone Number: +905063370548; Email: nilbavullu@gmail.com

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
• American Society of Anesthesiologists (ASA) physical status I-II-III
• BMI 18 to 40 kg/m2
• Elective thoracotomy surgery

Exclusion Criteria:

• Patient refusing the procedure
• Emergency surgery
• History of chronic opioid or analgesic used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic Paravertebral Block 20 ml; In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.	Procedure: TPVB with 20 ml; The thoracic paravertebral block will be applied to the patients with 20 ml of 0.25% bupivacaine under real-time ultrasound guidance.
Active Comparator: Thoracic Paravertebral Block 25 ml; In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 25 ml of 0.25% bupivacaine will be injected into this area.	Procedure: TPVB with 25 ml; The thoracic paravertebral block will be applied to the patients with 25 ml of 0.25% bupivacaine under real-time ultrasound guidance.
Active Comparator: Thoracic Paravertebral Block 30 ml; In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.	Procedure: TPVB with 30 ml; The thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine 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 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.
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).	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

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: January 7, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: E.Kurul-E1-22-3143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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