Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Thoracic paravertebral block-single injection; Thoracic paravertebral block-double injection
Intervention type(s): Procedure; Procedure
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients undergoing reduction mammaplasty, received single or double injection bilateral thoracic paravertebral block (TPVB) for postoperative analgesia
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Thoracic paravertebral blocks; Postoperative analgesia, numeric rating scale; Dermatomal blockade distribution; Postoperative time until first pain; Analgesic consumption; Reduction mammaplasty