Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty

NCT ID: NCT04596787

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Obesity Thoracic Paravertebral Blocks Ultrasound Performance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Bilateral Thoracic paravertebral block

Intervention Type PROCEDURE

The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

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.

Bilateral Thoracic paravertebral block

Intervention Type PROCEDURE

The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Interventions

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Bilateral Thoracic paravertebral block

The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Intervention Type PROCEDURE

Other Intervention Names

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TPVBs

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Presence of mental/psychiatric disorders
* Presence of chronic analgesic/opioid use
* Presence of alcohol/illicit drug use
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Emine Aysu Salviz, MD

MD, Attending Anesthesiologist, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine A Salviz, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

References

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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.

Reference Type RESULT
PMID: 24587923 (View on PubMed)

Franco 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.

Reference Type RESULT
PMID: 16551933 (View on PubMed)

Kula 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.

Reference Type RESULT
PMID: 28235511 (View on PubMed)

Salviz 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.

Reference Type DERIVED
PMID: 36763114 (View on PubMed)

Other Identifiers

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2020/964

Identifier Type: -

Identifier Source: org_study_id

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