Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

NCT ID: NCT05700357

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2024-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Paravertebral Block Thoracotomy Postoperative Analgesia Acute Pain Local Anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

TPVB with 20 ml

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

TPVB with 25 ml

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

TPVB with 30 ml

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Nilgün Zengin

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emine N ZENGİN

Role: CONTACT

+905063370548

Facility Contacts

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Emine N Zengin, MD

Role: primary

+905063370548

Other Identifiers

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E.Kurul-E1-22-3143

Identifier Type: -

Identifier Source: org_study_id

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