Clinical trial NCT04596787: Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Obesity
Thoracic Paravertebral Blocks
Ultrasound
Performance
Keywords: Obesity
Thoracic paravertebral blocks
Ultrasound-guidance
Performance difficulty
Satisfaction
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (obese and non-obese) required reduction mammoplasty surgery and received general anesthesia with TPVB analgesia

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.

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

Primary outcomes:
measure: Thoracic paravertebral block (TPVB) performance time
timeFrame: 0-20 minutes
Secondary outcomes:
measure: Postoperative numeric rating scale (NRS) pain scores
timeFrame: 0-24 hours
measure: Ideal US image visualization time
timeFrame: 0-5 minutes
measure: Difficulty of needle tip visualization
timeFrame: 0-20 minutes
measure: Number of needle maneuvers to reach the paravertebral space
timeFrame: 0-20 minutes
measure: Requirement of additional maneuver due to insufficient local anesthetic spread
timeFrame: 0-20 minutes
measure: Difficulty of TPVB according to the anesthesiologists
timeFrame: 0-20 minutes
measure: Length of stay in postoanesthesia care unit (PACU)
timeFrame: 0-1 hours
measure: Number of patients required fentanyl intraoperatively
timeFrame: Intraoperative 2-6 hours
measure: Time to postoperative first pain
timeFrame: 0-48 hours
measure: Number of paracetamol requirement through the postoperative first 24 hours
timeFrame: 0-24 hours
measure: Number of tramadol requirement through the postoperative first 24 hours
timeFrame: 0-24 hours
measure: Incidence of PONV through the postoperative first 24 hours
timeFrame: 0-24 hours
measure: Duration of sleep through the postoperative first 24 hours
timeFrame: 0-24 hours
measure: Length of hospital stay
timeFrame: 0-48 hours
measure: Patient satisfaction
timeFrame: 0-48 hours
measure: Surgeon satisfaction
timeFrame: 0-48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator
name: Emine A Salviz, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.