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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04596787
Enrollment
82
Registered
2020-10-22
Start date
2016-12-01
Completion date
2020-02-28
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thoracic paravertebral block (TPVB) performance time0-20 minutesTime 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

Secondary

MeasureTime frameDescription
Ideal US image visualization time0-5 minutesTime period between the US probe placement at T3-T4 level and visualizing the ideal image to perform the block
Difficulty of needle tip visualization0-20 minutesLikert scale: 1-5 (1:very poor, 5:very good)
Number of needle maneuvers to reach the paravertebral space0-20 minutesNumber of needle maneuvers to reach the paravertebral space (PVS)
Requirement of additional maneuver due to insufficient local anesthetic spread0-20 minutesRequirement of additional needle maneuver due to insufficient local anesthetic (LA) spread
Difficulty of TPVB according to the anesthesiologists0-20 minutesLikert scale: 1-5 (1:very poor, 5:very good)
Length of stay in postoanesthesia care unit (PACU)0-1 hoursModified Aldrete Scoring system (≥9/10)
Number of patients required fentanyl intraoperativelyIntraoperative 2-6 hoursIf 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.
Postoperative numeric rating scale (NRS) pain scores0-24 hoursNRS pain scores (0: no pain, 10: worst pain imaginable) through postoperative first 24 hours
Number of paracetamol requirement through the postoperative first 24 hours0-24 hoursParacetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative day 1)
Number of tramadol requirement through the postoperative first 24 hours0-24 hoursTramadol 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)
Incidence of PONV through the postoperative first 24 hours0-24 hoursNumber of feeling nausea or vomiting
Duration of sleep through the postoperative first 24 hours0-24 hoursTotal hours of sleep at first night
Length of hospital stay0-48 hoursPost Anaesthetic Discharge Scoring System (PADSS) (≥9/10)
Patient satisfaction0-48 hoursSatisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied
Surgeon satisfaction0-48 hoursSatisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied
Time to postoperative first pain0-48 hoursPostoperative first pain description (NRS ≥4) until discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026