The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
Primary Purpose
Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thoracic Paravertebral Block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- 18 to 80 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective video-assisted thoracoscopic surgery
Exclusion Criteria:
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo VATS
Sites / Locations
- Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
- Ankara City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Patients with a BMI of 18-24.9 kg/m2
Patients with a BMI of 25-29.9 kg/m2
Patients with a BMI of 30-40 kg/m2
Arm Description
The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
The needle will be advanced to the paravertebral area with an 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 assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours 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).
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
NCT ID
NCT05357976
First Posted
April 25, 2022
Last Updated
May 13, 2023
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05357976
Brief Title
The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
Official Title
The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 13, 2023 (Actual)
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
Obesity has become one of the world's leading health problems. It is known that obesity causes many diseases and negatively affects the quality of life. For this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. One of them is postoperative pain. Although there are studies stating that there is no relationship between body mass index (BMI) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. There are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in BMI.
After thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study will compare the effects of BMI on postoperative pain in patients undergoing TPVB for postoperative analgesia and thoracoscopic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block, Body Mass Index, Thoracic Surgery, Video-Assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with a BMI of 18-24.9 kg/m2
Arm Type
Active Comparator
Arm Description
The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
Arm Title
Patients with a BMI of 25-29.9 kg/m2
Arm Type
Active Comparator
Arm Description
The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
Arm Title
Patients with a BMI of 30-40 kg/m2
Arm Type
Active Comparator
Arm Description
The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Block
Intervention Description
Thoracic paravertebral block will be applied to the patients 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). Pain assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours after surgery.
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
ASA physical status I-II-III
BMI 18 to 40 kg/m2
Elective video-assisted thoracoscopic surgery
Exclusion Criteria:
Patient refusing the procedure
Emergency surgery
Chronic opioid or analgesic use
Patients who will operate under emergency conditions
Patients who will not undergo VATS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilgün Zengin, MD
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Keçiören
State/Province
Ankara
ZIP/Postal Code
06290
Country
Turkey
Facility Name
Ankara City Hospital
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06290
Country
Turkey
12. IPD Sharing Statement
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The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
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