Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700357
• Other study ID #: E.Kurul-E1-22-3143
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 28, 2024

Study information

• Verified date: February 2024
• Source: Ankara City Hospital Bilkent
• Contact: Emine N ZENGIN
• Phone: +905063370548
• Email: nilbavullu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 28, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Local Anesthetic
• Postoperative Analgesia
• Thoracic Paravertebral Block
• Thoracotomy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	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).	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