Pain, PostoperativeNCT05357976
The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
A study testing Thoracic Paravertebral Block in people with Pain, Postoperative and Acute Pain, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block
- What is being tested?
- Thoracic Paravertebral Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Apr 2022to 13 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective video-assisted thoracoscopic surgery
Who cannot join
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo VATS
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara City Hospital
Çankaya, Ankara, 06290
Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Keçiören, Ankara, 06290
About this study
Official title: The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery
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.
- Conditions
- Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block, Body Mass Index, Thoracic Surgery, Video-Assisted
- Being tested
- Thoracic Paravertebral Block
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Paravertebral BlockProcedure or surgery
Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a BMI of 18-24.9 kg/m2 | Active comparator | 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. Receives: Procedure: Thoracic Paravertebral Block |
| Patients with a BMI of 25-29.9 kg/m2 | Active comparator | 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. Receives: Procedure: Thoracic Paravertebral Block |
| Patients with a BMI of 30-40 kg/m2 | Active comparator | 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. Receives: Procedure: Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 48th-hour after surgery.
Secondary outcomes (1)
Morphine Consumption
Morphine consumption for 24 hours will be recorded
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start25 Apr 2022
- Primary completion1 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
- Investigators
- Nilgün Zengin, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357976
- Sponsor's protocol ID
- E.Kurul-E1-22-2596
- Status last verified
- May 2023
- First submitted
- 25 Apr 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37667207
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05357976
- Acronym / sponsor ID
- E.Kurul-E1-22-2596
- Conditions
- Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block, Body Mass Index, Thoracic Surgery, Video-Assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with a BMI of 18-24.9 kg/m2 | Active comparator | Procedure: Thoracic Paravertebral BlockThe 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 comparator | Procedure: Thoracic Paravertebral BlockThe 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 comparator | Procedure: Thoracic Paravertebral BlockThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective video-assisted thoracoscopic surgery
Key exclusion criteria (5 listed)
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo VATS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Paravertebral BlockThoracic paravertebral block will be applied to the patients under real-time ultrasound guidance. | Procedure or surgery | 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 |
Primary outcome
Pain Scores
Time frame: 1st hour after surgery.
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
Time frame: 2nd-hour after surgery.
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
Time frame: 4th-hour after surgery.
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
Time frame: 12th-hour after surgery.
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
Time frame: 24th-hour after surgery.
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
Time frame: 48th-hour after surgery.
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).
1 secondary outcome
Morphine Consumption
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 37667207Zengin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilgün Zengin, MD principal investigator
Ankara City Hospital Bilkent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Paravertebral Block in people with Pain, Postoperative and Acute Pain, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 1st hour after surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.