Pain, PostoperativeNCT04596787
Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty
An observational study of Pain, Postoperative and Obesity, run by Istanbul University.
Trial summary
Aim: Although regional anesthesia (RA) techniques are advantageous in the anesthetic management of obese patients (body mass index (BMI)≥30); their performances can still be associated with technical difficulties and greater failure rates. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative, Obesity, Thoracic Paravertebral Blocks
- What is being tested?
- Bilateral Thoracic paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 28 Feb 2020
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients (obese and non-obese) required reduction mammoplasty surgery and received general anesthesia with TPVB analgesia
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status of 1-3
- Capable of consenting
- Capable of understanding the instructions for using the NRS pain scores
- Capable of replying the questions
- Lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
- Absence of mental/psychiatric disorders
- Absence of chronic analgesic/opioid use
- Absence of alcohol/illicit drug use
Who cannot join
- Patient refusal of RA/TPVB performance
- American Society of Anesthesiologists (ASA) physical status of 4
- Not capable of consenting
- Not capable of understanding the instructions for using the NRS pain scores
- Not capable of replying the questions
- Contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
Show all 9Show fewer
- Presence of mental/psychiatric disorders
- Presence of chronic analgesic/opioid use
- Presence of alcohol/illicit drug use
About this study
Official title: The Performance Properties and Efficacy of Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty: A Historical Cohort Study
Aim: Although regional anesthesia (RA) techniques are advantageous in the anesthetic management of obese patients (body mass index (BMI)≥30); their performances can still be associated with technical difficulties and greater failure rates. The aim of this study is to compare the performance properties and analgesic efficacy of ultrasound (US)-guided bilateral thoracic paravertebral blocks (TPVBs) in obese and non-obese patients.
Material methods: After obtaining ethics committee approval; data of 82 patients, who underwent elective bilateral reduction mammaplasty under general anesthesia with adjunctive TPVB analgesia between December of 2016 and February of 2020, were reviewed. Patients were allocated into two groups with respect to their BMI scores (Group NO: BMI<30 and Group O: BMI≥30). Demographics, TPVB ideal US image visualization and performance times, needle tip visualisation and TPVB performance difficulties, number of needle maneuvers, surgical, anesthetic and analgesic follow-up parameters, incidence of postoperative nausea vomiting (PONV), sleep duration, length of postanesthesia care unit (PACU) and hospital stay, patient and surgeon satisfaction scores were all investigated and compared.
Read the detailed description
Aim: The number of obese patients (body mass index (BMI)≥30) has increased dramatically worldwide, and we, as anesthesiologists, routinely come up against them in our daily clinical practice. Although the preference of various peripheral and neuroaxial regional anesthesia (RA) techniques seems to be advantageous in the anesthetic management of these patients, their performances can also be associated with technical difficulties and greater failure rates. The aim of this study is to compare the performance properties and analgesic efficacy of ultrasound (US)-guided thoracic paravertebral blocks (TPVBs) in obese and non-obese patients.
Material methods: After obtaining ethics committee approval; data of 82 patients, who underwent elective bilateral reduction mammaplasty under general anesthesia with adjunctive TPVB analgesia between December of 2016 and February of 2020, were reviewed. Patients were allocated into two groups with respect to their BMI scores (Group NO: BMI<30 and Group O: BMI≥30). Demographics, TPVB ideal US image visualization and performance times, needle tip visualisation and TPVB performance difficulties, number of needle maneuvers, surgical, anesthetic and analgesic follow-up parameters, incidence of postoperative nausea vomiting (PONV), sleep duration, length of postanesthesia care unit (PACU) and hospital stay, patient and surgeon satisfaction scores were all investigated and compared. Student's t, Mann-Whitney-U and Chi-square tests were used for statistical analysis.
- Being tested
- Bilateral Thoracic paravertebral block
- Keywords
- Obesity, Thoracic paravertebral blocks, Ultrasound-guidance, Performance difficulty, Satisfaction
- Medical subject headings
- Pain, Postoperative, Obesity, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Thoracic paravertebral blockProcedure or surgery
Also called TPVBs
The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
| Study group | Role | What they receive |
|---|---|---|
| Non-Obese Patients (Group NO: body mass index (BMI) <30) | Patients received bilateral single injection ultrasound (US)-guided bilateral thoracic paravertebral block (TPVB) at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side. Receives: Procedure: Bilateral Thoracic paravertebral block | |
| Obese Patients (Group O: body mass index (BMI) ≥30) | Patients received bilateral single injection ultrasound (US)-guided bilateral thoracic paravertebral block (TPVB) at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side. Receives: Procedure: Bilateral Thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic paravertebral block (TPVB) performance time
Time period between the US probe placement to the right side at T3-T4 level and the needle withdrawal from the left side T3-T4 level
Measured: 0-20 minutes
Secondary outcomes (16)
Postoperative numeric rating scale (NRS) pain scores
NRS pain scores (0: no pain, 10: worst pain imaginable) through postoperative first 24 hours
Measured: 0-24 hours
Ideal US image visualization time
Time period between the US probe placement at T3-T4 level and visualizing the ideal image to perform the block
Measured: 0-5 minutes
Difficulty of needle tip visualization
Likert scale: 1-5 (1:very poor, 5:very good)
Measured: 0-20 minutes
Number of needle maneuvers to reach the paravertebral space
Number of needle maneuvers to reach the paravertebral space (PVS)
Measured: 0-20 minutes
Requirement of additional maneuver due to insufficient local anesthetic spread
Requirement of additional needle maneuver due to insufficient local anesthetic (LA) spread
Measured: 0-20 minutes
Difficulty of TPVB according to the anesthesiologists
Likert scale: 1-5 (1:very poor, 5:very good)
Measured: 0-20 minutes
Length of stay in postoanesthesia care unit (PACU)
Modified Aldrete Scoring system (≥9/10)
Measured: 0-1 hours
Number of patients required fentanyl intraoperatively
If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously.
Measured: Intraoperative 2-6 hours
Time to postoperative first pain
Postoperative first pain description (NRS ≥4) until discharge
Measured: 0-48 hours
Number of paracetamol requirement through the postoperative first 24 hours
Paracetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative day 1)
Measured: 0-24 hours
Number of tramadol requirement through the postoperative first 24 hours
Tramadol was used when postoperative pain NRS ≥4 again after 1 hour of paracetamol application in the postanesthesia care unit or on the wards (on postoperative day 1)
Measured: 0-24 hours
Incidence of PONV through the postoperative first 24 hours
Number of feeling nausea or vomiting
Measured: 0-24 hours
Duration of sleep through the postoperative first 24 hours
Total hours of sleep at first night
Measured: 0-24 hours
Length of hospital stay
Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)
Measured: 0-48 hours
Patient satisfaction
Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied
Measured: 0-48 hours
Surgeon satisfaction
Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2016
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Istanbul UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aysu Salviz, MD, Istanbul University
- Investigators
- Emine A Salviz, Assoc Prof, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596787
- Sponsor's protocol ID
- 2020/964
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilicaslan A, Topal A, Erol A, Borazan H, Bilge O, Otelcioglu S. Ultrasound-guided multiple peripheral nerve blocks in a superobese patient. Case Rep Anesthesiol. 2014;2014:896914. doi: 10.1155/2014/896914. Epub 2014 Jan 22.
PubMed 24587923Franco CD, Gloss FJ, Voronov G, Tyler SG, Stojiljkovic LS. Supraclavicular block in the obese population: an analysis of 2020 blocks. Anesth Analg. 2006 Apr;102(4):1252-4. doi: 10.1213/01.ane.0000198341.53062.a2.
PubMed 16551933Kula AO, Riess ML, Ellinas EH. Increasing body mass index predicts increasing difficulty, failure rate, and time to discovery of failure of epidural anesthesia in laboring patients. J Clin Anesth. 2017 Feb;37:154-158. doi: 10.1016/j.jclinane.2016.11.010. Epub 2017 Jan 10.
PubMed 28235511Salviz EA, Bingul ES, Guzel M, Savran Karadeniz M, Turhan O, Emre Demirel E, Saka E. Comparison of Performance Characteristics and Efficacy of Bilateral Thoracic Paravertebral Blocks in Obese and Non-Obese Patients Undergoing Reduction Mammaplasty Surgery: A Historical Cohort Study. Aesthetic Plast Surg. 2023 Aug;47(4):1343-1352. doi: 10.1007/s00266-023-03270-w. Epub 2023 Feb 10.
PubMed 36763114
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance Properties and Efficacy of Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT04596787
- Acronym / sponsor ID
- 2020/964
- Keywords
- Obesity, Thoracic paravertebral blocks, Ultrasound-guidance, Performance difficulty, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 22 Oct 2020 (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.
Aim: Although regional anesthesia (RA) techniques are advantageous in the anesthetic management of obese patients (body mass index (BMI)≥30); their performances can still be associated with technical difficulties and greater failure rates. The aim of this study is to compare the performance properties and analgesic efficacy of ultrasound (US)-guided bilateral thoracic paravertebral blocks (TPVBs) in obese and non-obese patients.
Material methods: After obtaining ethics committee approval; data of 82 patients, who underwent elective bilateral reduction mammaplasty under general anesthesia with adjunctive TPVB analgesia between December of 2016 and February of 2020, were reviewed. Patients were allocated into two groups with respect to their BMI scores (Group NO: BMI<30 and Group O: BMI≥30). Demographics, TPVB ideal US image visualization and performance times, needle tip visualisation and TPVB performance difficulties, number of needle maneuvers, surgical, anesthetic and analgesic follow-up parameters, incidence of postoperative nausea vomiting (PONV), sleep duration, length of postanesthesia care unit (PACU) and hospital stay, patient and surgeon satisfaction scores were all investigated and compared.
Detailed description
Aim: The number of obese patients (body mass index (BMI)≥30) has increased dramatically worldwide, and we, as anesthesiologists, routinely come up against them in our daily clinical practice. Although the preference of various peripheral and neuroaxial regional anesthesia (RA) techniques seems to be advantageous in the anesthetic management of these patients, their performances can also be associated with technical difficulties and greater failure rates. The aim of this study is to compare the performance properties and analgesic efficacy of ultrasound (US)-guided thoracic paravertebral blocks (TPVBs) in obese and non-obese patients.
Material methods: After obtaining ethics committee approval; data of 82 patients, who underwent elective bilateral reduction mammaplasty under general anesthesia with adjunctive TPVB analgesia between December of 2016 and February of 2020, were reviewed. Patients were allocated into two groups with respect to their BMI scores (Group NO: BMI<30 and Group O: BMI≥30). Demographics, TPVB ideal US image visualization and performance times, needle tip visualisation and TPVB performance difficulties, number of needle maneuvers, surgical, anesthetic and analgesic follow-up parameters, incidence of postoperative nausea vomiting (PONV), sleep duration, length of postanesthesia care unit (PACU) and hospital stay, patient and surgeon satisfaction scores were all investigated and compared. Student's t, Mann-Whitney-U and Chi-square tests were used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Obese Patients (Group NO: body mass index (BMI) <30) | – | Procedure: Bilateral Thoracic paravertebral blockPatients received bilateral single injection ultrasound (US)-guided bilateral thoracic paravertebral block (TPVB) at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side. |
| Obese Patients (Group O: body mass index (BMI) ≥30) | – | Procedure: Bilateral Thoracic paravertebral blockPatients received bilateral single injection ultrasound (US)-guided bilateral thoracic paravertebral block (TPVB) at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (obese and non-obese) required reduction mammoplasty surgery and received general anesthesia with TPVB analgesia
Key inclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) physical status of 1-3
- Capable of consenting
- Capable of understanding the instructions for using the NRS pain scores
- Capable of replying the questions
- Lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
Key exclusion criteria (9 listed)
- Patient refusal of RA/TPVB performance
- American Society of Anesthesiologists (ASA) physical status of 4
- Not capable of consenting
- Not capable of understanding the instructions for using the NRS pain scores
- Not capable of replying the questions
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 |
|---|---|---|
| Bilateral Thoracic paravertebral blockAlso: TPVBsThe blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area). | Procedure or surgery | Non-Obese Patients (Group NO: body mass index (BMI) <30), Obese Patients (Group O: body mass index (BMI) ≥30) |
Primary outcome
Thoracic paravertebral block (TPVB) performance time
Time frame: 0-20 minutes
Time period between the US probe placement to the right side at T3-T4 level and the needle withdrawal from the left side T3-T4 level
16 secondary outcomes
Postoperative numeric rating scale (NRS) pain scores
Time frame: 0-24 hours
Ideal US image visualization time
Time frame: 0-5 minutes
Difficulty of needle tip visualization
Time frame: 0-20 minutes
Number of needle maneuvers to reach the paravertebral space
Time frame: 0-20 minutes
Requirement of additional maneuver due to insufficient local anesthetic spread
Time frame: 0-20 minutes
Difficulty of TPVB according to the anesthesiologists
Time frame: 0-20 minutes
Length of stay in postoanesthesia care unit (PACU)
Time frame: 0-1 hours
Number of patients required fentanyl intraoperatively
Time frame: Intraoperative 2-6 hours
Time to postoperative first pain
Time frame: 0-48 hours
Number of paracetamol requirement through the postoperative first 24 hours
Time frame: 0-24 hours
Number of tramadol requirement through the postoperative first 24 hours
Time frame: 0-24 hours
Incidence of PONV through the postoperative first 24 hours
Time frame: 0-24 hours
Duration of sleep through the postoperative first 24 hours
Time frame: 0-24 hours
Length of hospital stay
Time frame: 0-48 hours
Patient satisfaction
Time frame: 0-48 hours
Surgeon satisfaction
Time frame: 0-48 hours
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 22 Oct 2020.
- Results publication: PubMed 24587923Kilicaslan A, Topal A, Erol A, Borazan H, Bilge O, Otelcioglu S. Ultrasound-guided multiple peripheral nerve blocks in a superobese patient. Case Rep Anesthesiol. 2014;2014:896914. doi: 10.1155/2014/896914. Epub 2014 Jan 22.
- Results publication: PubMed 16551933Franco CD, Gloss FJ, Voronov G, Tyler SG, Stojiljkovic LS. Supraclavicular block in the obese population: an analysis of 2020 blocks. Anesth Analg. 2006 Apr;102(4):1252-4. doi: 10.1213/01.ane.0000198341.53062.a2.
- Results publication: PubMed 28235511Kula AO, Riess ML, Ellinas EH. Increasing body mass index predicts increasing difficulty, failure rate, and time to discovery of failure of epidural anesthesia in laboring patients. J Clin Anesth. 2017 Feb;37:154-158. doi: 10.1016/j.jclinane.2016.11.010. Epub 2017 Jan 10.
- Derived from this study: PubMed 36763114Salviz EA, Bingul ES, Guzel M, Savran Karadeniz M, Turhan O, Emre Demirel E, Saka E. Comparison of Performance Characteristics and Efficacy of Bilateral Thoracic Paravertebral Blocks in Obese and Non-Obese Patients Undergoing Reduction Mammaplasty Surgery: A Historical Cohort Study. Aesthetic Plast Surg. 2023 Aug;47(4):1343-1352. doi: 10.1007/s00266-023-03270-w. Epub 2023 Feb 10.
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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.
Emine A Salviz, Assoc Prof principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Obesity, run by Istanbul University.
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 8 inclusion and 9 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Thoracic paravertebral block (TPVB) performance time (time frame: 0-20 minutes). 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 NCT04596787, which also lists 4 linked publications.
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 22 Oct 2020.