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Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

Primary Purpose

Thoracic Paravertebral Block, Thoracotomy, Postoperative Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TPVB with 20 ml
TPVB with 25 ml
TPVB with 30 ml
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Paravertebral Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Thoracic Paravertebral Block 20 ml

Thoracic Paravertebral Block 25 ml

Thoracic Paravertebral Block 30 ml

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

Morphine Consumption
Morphine consumption for 24 hours will be recorded

Full Information

First Posted
January 7, 2023
Last Updated
January 17, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05700357
Brief Title
Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia
Official Title
Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Paravertebral Block, Thoracotomy, Postoperative Analgesia, Acute Pain, Local Anesthetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic Paravertebral Block 20 ml
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thoracic Paravertebral Block 25 ml
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thoracic Paravertebral Block 30 ml
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TPVB with 20 ml
Intervention Description
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
Intervention Name(s)
TPVB with 25 ml
Intervention Description
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
Intervention Name(s)
TPVB with 30 ml
Intervention Description
The thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine under real-time ultrasound guidance.
Primary Outcome Measure Information:
Title
Pain Scores
Description
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).
Time Frame
1st hour after surgery
Title
Pain Scores
Description
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).
Time Frame
2nd-hour after surgery
Title
Pain Scores
Description
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).
Time Frame
4th-hour after surgery
Title
Pain Scores
Description
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).
Time Frame
12th-hour after surgery.
Title
Pain Scores
Description
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).
Time Frame
24th-hour after surgery.
Title
Pain Scores
Description
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).
Time Frame
48th-hour after surgery.
Secondary Outcome Measure Information:
Title
Morphine Consumption
Description
Morphine consumption for 24 hours will be recorded
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emine N ZENGİN
Phone
+905063370548
Email
nilbavullu@yahoo.com
Facility Information:
Facility Name
Ankara City Hospital
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06290
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine N Zengin, MD
Phone
+905063370548
Email
nilbavullu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

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