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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04596787
Other study ID # 2020/964
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2016
Est. completion date February 28, 2020

Study information

Verified date October 2020
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 82
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Thoracic paravertebral block (TPVB) performance time 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 0-20 minutes
Secondary Postoperative numeric rating scale (NRS) pain scores NRS pain scores (0: no pain, 10: worst pain imaginable) through postoperative first 24 hours 0-24 hours
Secondary Ideal US image visualization time Time period between the US probe placement at T3-T4 level and visualizing the ideal image to perform the block 0-5 minutes
Secondary Difficulty of needle tip visualization Likert scale: 1-5 (1:very poor, 5:very good) 0-20 minutes
Secondary Number of needle maneuvers to reach the paravertebral space Number of needle maneuvers to reach the paravertebral space (PVS) 0-20 minutes
Secondary Requirement of additional maneuver due to insufficient local anesthetic spread Requirement of additional needle maneuver due to insufficient local anesthetic (LA) spread 0-20 minutes
Secondary Difficulty of TPVB according to the anesthesiologists Likert scale: 1-5 (1:very poor, 5:very good) 0-20 minutes
Secondary Length of stay in postoanesthesia care unit (PACU) Modified Aldrete Scoring system (=9/10) 0-1 hours
Secondary Number of patients required fentanyl intraoperatively 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. Intraoperative 2-6 hours
Secondary Time to postoperative first pain Postoperative first pain description (NRS =4) until discharge 0-48 hours
Secondary Number of paracetamol requirement through the postoperative first 24 hours Paracetamol was used when postoperative pain NRS =4 in the postanesthesia care unit or on the wards (on postoperative day 1) 0-24 hours
Secondary Number of tramadol requirement through the postoperative first 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) 0-24 hours
Secondary Incidence of PONV through the postoperative first 24 hours Number of feeling nausea or vomiting 0-24 hours
Secondary Duration of sleep through the postoperative first 24 hours Total hours of sleep at first night 0-24 hours
Secondary Length of hospital stay Post Anaesthetic Discharge Scoring System (PADSS) (=9/10) 0-48 hours
Secondary Patient satisfaction Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied 0-48 hours
Secondary Surgeon satisfaction Satisfaction score during hospital discharge: 0: very unsatisfied, 3: very satisfied 0-48 hours
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