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

Completed
Conditions
Obesity
Pain, Postoperative
Performance
Thoracic Paravertebral Blocks
Ultrasound
Interventions
Procedure: Bilateral Thoracic paravertebral block
Registration Number
NCT04596787
Lead Sponsor
Istanbul University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
82
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non-Obese Patients (Group NO: body mass index (BMI) <30)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)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.
Primary Outcome Measures
NameTimeMethod
Thoracic paravertebral block (TPVB) performance time0-20 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 Outcome Measures
NameTimeMethod
Postoperative numeric rating scale (NRS) pain scores0-24 hours

NRS pain scores (0: no pain, 10: worst pain imaginable) through postoperative first 24 hours

Difficulty of needle tip visualization0-20 minutes

Likert scale: 1-5 (1:very poor, 5:very good)

Requirement of additional maneuver due to insufficient local anesthetic spread0-20 minutes

Requirement of additional needle maneuver due to insufficient local anesthetic (LA) spread

Difficulty of TPVB according to the anesthesiologists0-20 minutes

Likert scale: 1-5 (1:very poor, 5:very good)

Time to postoperative first pain0-48 hours

Postoperative first pain description (NRS ≥4) until discharge

Number of patients required fentanyl intraoperativelyIntraoperative 2-6 hours

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.

Number of paracetamol requirement through the postoperative first 24 hours0-24 hours

Paracetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative day 1)

Incidence of PONV through the postoperative first 24 hours0-24 hours

Number of feeling nausea or vomiting

Duration of sleep through the postoperative first 24 hours0-24 hours

Total hours of sleep at first night

Ideal US image visualization time0-5 minutes

Time period between the US probe placement at T3-T4 level and visualizing the ideal image to perform the block

Number of needle maneuvers to reach the paravertebral space0-20 minutes

Number of needle maneuvers to reach the paravertebral space (PVS)

Number of tramadol requirement through the postoperative first 24 hours0-24 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)

Patient satisfaction0-48 hours

Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied

Length of stay in postoanesthesia care unit (PACU)0-1 hours

Modified Aldrete Scoring system (≥9/10)

Length of hospital stay0-48 hours

Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

Surgeon satisfaction0-48 hours

Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied

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