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

NCT04596787 | Completed

• 1 other identifier: 2020/964
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pain, Postoperative; Obesity; Thoracic Paravertebral Blocks; Ultrasound; Performance

Keywords

Obesity; Thoracic paravertebral blocks; Ultrasound-guidance; Performance difficulty; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

  0-20 minutes

Secondary Outcomes (16)

• Postoperative numeric rating scale (NRS) pain scores

  0-24 hours

• Ideal US image visualization time

  0-5 minutes

• Difficulty of needle tip visualization

  0-20 minutes

• Number of needle maneuvers to reach the paravertebral space

  0-20 minutes

• Requirement of additional maneuver due to insufficient local anesthetic spread

  0-20 minutes

Study Arms (2)

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.

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.

Procedure: Bilateral Thoracic paravertebral block

Interventions

Bilateral Thoracic paravertebral block PROCEDURE

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

Also known as: TPVBs

Non-Obese Patients (Group NO: body mass index (BMI) <30); Obese Patients (Group O: body mass index (BMI) ≥30)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (obese and non-obese) required reduction mammoplasty surgery and received general anesthesia with TPVB analgesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (4)

• 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.

  PMID: 24587923 RESULT

• 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.

  PMID: 16551933 RESULT

• 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.

  PMID: 28235511 RESULT

• 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.

  PMID: 36763114 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Obesity; Personal Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Behavior

Study Officials

• Emine A Salviz, Assoc Prof

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending Anesthesiologist, Associate Professor

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2016
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10