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Clinical Trials/NCT04596787
NCT04596787
Completed
Not Applicable

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

Istanbul University0 sites82 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Istanbul University
Enrollment
82
Primary Endpoint
Thoracic paravertebral block (TPVB) performance time
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emine Aysu Salviz, MD

MD, Attending Anesthesiologist, Associate Professor

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Postoperative numeric rating scale (NRS) pain scores(0-24 hours)
  • Difficulty of needle tip visualization(0-20 minutes)
  • Requirement of additional maneuver due to insufficient local anesthetic spread(0-20 minutes)
  • Difficulty of TPVB according to the anesthesiologists(0-20 minutes)
  • Time to postoperative first pain(0-48 hours)
  • Number of patients required fentanyl intraoperatively(Intraoperative 2-6 hours)
  • Number of paracetamol requirement through the postoperative first 24 hours(0-24 hours)
  • Incidence of PONV through the postoperative first 24 hours(0-24 hours)
  • Duration of sleep through the postoperative first 24 hours(0-24 hours)
  • Ideal US image visualization time(0-5 minutes)
  • Number of needle maneuvers to reach the paravertebral space(0-20 minutes)
  • Number of tramadol requirement through the postoperative first 24 hours(0-24 hours)
  • Patient satisfaction(0-48 hours)
  • Length of stay in postoanesthesia care unit (PACU)(0-1 hours)
  • Length of hospital stay(0-48 hours)
  • Surgeon satisfaction(0-48 hours)

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