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Completed

NCT Number: NCT04596787

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: TPVBs

Primary outcomes

  1. 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

  1. Postoperative numeric rating scale (NRS) pain scores

    Time frame: 0-24 hours

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

  2. Ideal US image visualization time

    Time frame: 0-5 minutes

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

  3. Difficulty of needle tip visualization

    Time frame: 0-20 minutes

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

  4. Number of needle maneuvers to reach the paravertebral space

    Time frame: 0-20 minutes

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

  5. Requirement of additional maneuver due to insufficient local anesthetic spread

    Time frame: 0-20 minutes

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

  6. Difficulty of TPVB according to the anesthesiologists

    Time frame: 0-20 minutes

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

  7. Length of stay in postoanesthesia care unit (PACU)

    Time frame: 0-1 hours

    Modified Aldrete Scoring system (≥9/10)

  8. Number of patients required fentanyl intraoperatively

    Time frame: Intraoperative 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.

  9. Time to postoperative first pain

    Time frame: 0-48 hours

    Postoperative first pain description (NRS ≥4) until discharge

  10. Number of paracetamol requirement through the postoperative first 24 hours

    Time frame: 0-24 hours

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

  11. Number of tramadol requirement through the postoperative first 24 hours

    Time frame: 0-24 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)

  12. Incidence of PONV through the postoperative first 24 hours

    Time frame: 0-24 hours

    Number of feeling nausea or vomiting

  13. Duration of sleep through the postoperative first 24 hours

    Time frame: 0-24 hours

    Total hours of sleep at first night

  14. Length of hospital stay

    Time frame: 0-48 hours

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

  15. Patient satisfaction

    Time frame: 0-48 hours

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

  16. Surgeon satisfaction

    Time frame: 0-48 hours

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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