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Completed

NCT Number: NCT04517331

Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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 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
  • Absence of chronic analgesic/opioid use
  • Absence of alcohol/illicit drug use

Exclusion criteria

  • Patient refusal
  • 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 study-based 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

Thoracic paravertebral block-single injection

Procedure

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

Thoracic paravertebral block-double injection

Procedure

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).

Primary outcomes

  1. Pain (Numeric rating scale (NRS)) score

    Time frame: 12th hour

    NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour

Secondary outcomes

  1. Pain (Numeric rating scale (NRS)) score

    Time frame: 0-48 hours

    NRS pain scores (0: no pain, 10: worst pain imaginable) on postoperative 0th min, 1st, 2nd, 6th, 24th and 48th hours on both sides

  2. Dermatomal blockade distribution/numbers of blocked dermatomes

    Time frame: 0-30 minutes

    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.

  3. Dermatomal blockade distribution/numbers of blocked dermatomes

    Time frame: 0-48 hours

    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.

  4. Block application time

    Time frame: 2-20 minutes

    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.

  5. Number of patients experienced hypotension intraoperatively

    Time frame: Intraoperative 2-4 hours

    The mean arterial pressure (MAP) decreased >20% below preinduction value

  6. Number of patients required fentanyl intraoperatively

    Time frame: Intraoperative 2-4 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.

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

    Time frame: 0-1 hours

    Discharge from PACU was determined using the White Fast tracking score ≥12, whereas none of the parameters was <1 in any category

  8. Postoperative time until first pain

    Time frame: 0-48 hours

    Postoperative first pain description (NRS ≥4)

  9. Paracetamol consumption/the total numbers of paracetamol requirements

    Time frame: 0-48 hours

    Paracetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)

  10. Tramadol consumption/the total numbers of tramadol requirements

    Time frame: 0-48 hours

    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)

  11. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 0-48 hours

    Number of feeling nausea or vomiting (on postoperative days 1 and 2)

  12. Duration of sleep

    Time frame: 0-48 hours

    Total hours of sleep per day (on postoperative days 1 and 2)

  13. Patient satisfaction

    Time frame: 0-48 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

  14. Surgeon satisfaction

    Time frame: 0-48 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparison of Single and Double Injection Ultrasound-Guided Bilateral Thoracic Paravertebral Block Effects in Patients Undergoing Reduction Mammaplasty: A Prospective Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2020
Registry last updated
Aug 25, 2020

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

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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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