The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
1 other identifier
interventional
75
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2023
CompletedMay 16, 2023
May 1, 2023
1 year
April 25, 2022
May 13, 2023
Conditions
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). Pain assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours after surgery.
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)
Patients with a BMI of 18-24.9 kg/m2
ACTIVE COMPARATORThe 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.
Patients with a BMI of 25-29.9 kg/m2
ACTIVE COMPARATORThe 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.
Patients with a BMI of 30-40 kg/m2
ACTIVE COMPARATORThe 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.
Interventions
Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
Eligibility Criteria
You may qualify if:
- to 80 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective video-assisted thoracoscopic surgery
You may not qualify if:
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo VATS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ankara City Hospital
Çankaya, Ankara, 06290, Turkey (Türkiye)
Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Keçiören, Ankara, 06290, Turkey (Türkiye)
Related Publications (1)
Zengin EN, Alagoz A, Yigit H, Sazak H, Sekerci S, Zengin M. The effect of body mass index on thoracic paravertebral block analgesia after video-assisted thoracoscopic surgery; a prospective interventional study. BMC Anesthesiol. 2023 Sep 4;23(1):297. doi: 10.1186/s12871-023-02264-0.
PMID: 37667207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilgün Zengin, MD
Ankara City Hospital Bilkent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal İnvestigator
Study Record Dates
First Submitted
April 25, 2022
First Posted
May 3, 2022
Study Start
April 25, 2022
Primary Completion
May 1, 2023
Study Completion
May 13, 2023
Last Updated
May 16, 2023
Record last verified: 2023-05