This study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty. After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The patients were randomized in one of single (Group S: T3-T4) or double injections (Group D: T2-T3\&T4-T5) bilateral TPVB groups (bupivacaine 0.375% 20 mL per side). All patients' dermatomal blockade distributions (T2-T6) were followed for 30 minutes, and then they were given general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. Postoperatively, patients in both groups received IV paracetamol 1 g when numeric rating scale (NRS) pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain scores at postoperative 12th hour. The secondary endpoints were NRS scores and dermatomal blockade distributions through the postoperative first 48 hours, postoperative time until first pain, the total numbers of analgesic requirements on days 1 and 2.
This prospective randomized controlled study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty. After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The inclusion criteria were female gender, aging between 18 and 70 years, American Society of Anesthesiologists (ASA) physical status of 1-3, capable of consenting, understanding the instructions for using the NRS pain scores and replying the study-based questions, lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB, absence of mental/psychiatric disorders, chronic analgesic/opioid use and alcohol/illicit drug use. The patients were randomized in one of single (Group S: T3-T4-bupivacaine 0.375% 20 mL/injection) or double injections (Group D: T2-T3\&T4-T5-bupivacaine 0.375% 10 mL/injection) bilateral TPVB groups using the sealed envelopes technique. All patients' dermatomal (sensorial) blockade distributions (T2-T6) were tested bilaterally between T2 and T6 dermatomal levels on the midclavicular line in every 5 minutes through the first 30 minutes after TPVB performances, by using the pin-prick test, and then they were given standard general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. The NRS pain scores (0: no pain and 10: worst pain imaginable), and the dermatomal blockade distribution/numbers of blocked dermatomes of all patients on both sides were asked and documented on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours. Postoperatively, patients in both groups received IV paracetamol 1 g when NRS pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain score at 12th hour. The secondary endpoints included the NRS pain scores and the dermatomal blockade distribution/numbers of blocked dermatomes through the postoperative first 48 hours, block application times, number of patients experienced hypotension or required fentanyl intraoperatively, length of stay in postoperative care unit (PACU), postoperative time until first pain (NRS≥4), the total numbers of paracetamol and tramadol requirements, incidence of postoperative nausea and vomiting (PONV) and duration of sleep on postoperative days 1 and 2, patient and surgeon satisfaction scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
The blocks were performed at both T2-T3 and T4-T5 levels bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Pain (Numeric rating scale (NRS)) score
NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour
Time frame: 12th hour
Pain (Numeric rating scale (NRS)) score
NRS pain scores (0: no pain, 10: worst pain imaginable) on postoperative 0th min, 1st, 2nd, 6th, 24th and 48th hours on both sides
Time frame: 0-48 hours
Dermatomal blockade distribution/numbers of blocked dermatomes
Preoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients in every 5 min through the first 30 min after TPVB performances, by using the pin-prick test. Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides. The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.
Time frame: 0-30 minutes
Dermatomal blockade distribution/numbers of blocked dermatomes
Postoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours, by using the pin-prick test. Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides. The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.
Time frame: 0-48 hours
Block application time
The bilateral TPVB application time was defined as the time period between the needle insertion at the first determined level and the needle withdrawal from the last determined level.
Time frame: 2-20 minutes
Number of patients experienced hypotension intraoperatively
The mean arterial pressure (MAP) decreased \>20% below preinduction value
Time frame: Intraoperative 2-4 hours
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.
Time frame: Intraoperative 2-4 hours
Length of stay in postoanesthesia care unit (PACU)
Discharge from PACU was determined using the White Fast tracking score ≥12, whereas none of the parameters was \<1 in any category
Time frame: 0-1 hours
Postoperative time until first pain
Postoperative first pain description (NRS ≥4)
Time frame: 0-48 hours
Paracetamol consumption/the total numbers of paracetamol requirements
Paracetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)
Time frame: 0-48 hours
Tramadol consumption/the total numbers of tramadol requirements
Tramadol was used when postoperative pain NRS ≥4 again after 1 h of paracetamol application in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)
Time frame: 0-48 hours
Incidence of postoperative nausea and vomiting (PONV)
Number of feeling nausea or vomiting (on postoperative days 1 and 2)
Time frame: 0-48 hours
Duration of sleep
Total hours of sleep per day (on postoperative days 1 and 2)
Time frame: 0-48 hours
Patient satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time frame: 0-48 hours
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time frame: 0-48 hours
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