Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

NCT05700357 | Recruiting

• 1 other identifier: E.Kurul-E1-22-3143
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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 Outcomes (1)

• Morphine Consumption

  24 hours after surgery

Study Arms (3)

Thoracic Paravertebral Block 20 ml

ACTIVE COMPARATOR

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

Thoracic Paravertebral Block 25 ml

ACTIVE COMPARATOR

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

Thoracic Paravertebral Block 30 ml

ACTIVE COMPARATOR

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

Interventions

TPVB with 20 ml PROCEDURE

The thoracic paravertebral block will be applied to the patients with 20 ml of 0.25% bupivacaine under real-time ultrasound guidance.

Thoracic Paravertebral Block 20 ml

TPVB with 25 ml PROCEDURE

The thoracic paravertebral block will be applied to the patients with 25 ml of 0.25% bupivacaine under real-time ultrasound guidance.

Thoracic Paravertebral Block 25 ml

TPVB with 30 ml PROCEDURE

The thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine under real-time ultrasound guidance.

Thoracic Paravertebral Block 30 ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• BMI 18 to 40 kg/m2
• Elective thoracotomy surgery

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 06290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emine N ZENGİN

CONTACT

+905063370548; nilbavullu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 26, 2023
• Study Start: December 28, 2022
• Primary Completion: November 28, 2024
• Study Completion: December 28, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)