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Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thoracic paravertebral block-single injection
Thoracic paravertebral block-double injection
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Thoracic paravertebral blocks, Postoperative analgesia, numeric rating scale, Dermatomal blockade distribution, Postoperative time until first pain, Analgesic consumption, Reduction mammaplasty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University, Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group S (single injection TPVB group)

Group D (double injection TPVB group)

Arm Description

Patients received bilateral single injection ultrasound-guided TPVB at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side.

Patients received bilateral double injection ultrasound-guided TPVB at the level of T2-T3 and T4-T5 with 10 mL bupivacaine 0.375% per injection (20 mL bupivacaine 0.375% per side as the single injection group).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
Number of patients experienced hypotension intraoperatively
The mean arterial pressure (MAP) decreased >20% below preinduction value
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.
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
Postoperative time until first pain
Postoperative first pain description (NRS ≥4)
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)
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)
Incidence of postoperative nausea and vomiting (PONV)
Number of feeling nausea or vomiting (on postoperative days 1 and 2)
Duration of sleep
Total hours of sleep per day (on postoperative days 1 and 2)
Patient satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied

Full Information

First Posted
August 16, 2020
Last Updated
August 21, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04517331
Brief Title
Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty
Official Title
Comparison of Single and Double Injection Ultrasound-Guided Bilateral Thoracic Paravertebral Block Effects in Patients Undergoing Reduction Mammaplasty: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Thoracic paravertebral blocks, Postoperative analgesia, numeric rating scale, Dermatomal blockade distribution, Postoperative time until first pain, Analgesic consumption, Reduction mammaplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients undergoing reduction mammaplasty, received single or double injection bilateral thoracic paravertebral block (TPVB) for postoperative analgesia
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
All TPVB procedures were performed by the same 3 senior anesthesiology residents, always under the supervision of 2 attending anesthesiologists (1 senior resident with 1 attending anesthesiologist at a time) Preoperatively, the anesthesiologists who were blinded to the group of that specific patient evaluated the sensorial blockade of dermatomes separately on both sides Postoperatively, different anesthesiologists who did not participate in the TPVB performance process of that specific patient and were totally blinded to the group again collected the data. Surgeons were also blinded.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S (single injection TPVB group)
Arm Type
Active Comparator
Arm Description
Patients received bilateral single injection ultrasound-guided TPVB at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side.
Arm Title
Group D (double injection TPVB group)
Arm Type
Active Comparator
Arm Description
Patients received bilateral double injection ultrasound-guided TPVB at the level of T2-T3 and T4-T5 with 10 mL bupivacaine 0.375% per injection (20 mL bupivacaine 0.375% per side as the single injection group).
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block-single injection
Intervention Description
The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block-double injection
Intervention Description
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 Outcome Measure Information:
Title
Pain (Numeric rating scale (NRS)) score
Description
NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour
Time Frame
12th hour
Secondary Outcome Measure Information:
Title
Pain (Numeric rating scale (NRS)) score
Description
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
Title
Dermatomal blockade distribution/numbers of blocked dermatomes
Description
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
Title
Dermatomal blockade distribution/numbers of blocked dermatomes
Description
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
Title
Block application time
Description
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
Title
Number of patients experienced hypotension intraoperatively
Description
The mean arterial pressure (MAP) decreased >20% below preinduction value
Time Frame
Intraoperative 2-4 hours
Title
Number of patients required fentanyl intraoperatively
Description
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
Title
Length of stay in postoanesthesia care unit (PACU)
Description
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
Title
Postoperative time until first pain
Description
Postoperative first pain description (NRS ≥4)
Time Frame
0-48 hours
Title
Paracetamol consumption/the total numbers of paracetamol requirements
Description
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
Title
Tramadol consumption/the total numbers of tramadol requirements
Description
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
Title
Incidence of postoperative nausea and vomiting (PONV)
Description
Number of feeling nausea or vomiting (on postoperative days 1 and 2)
Time Frame
0-48 hours
Title
Duration of sleep
Description
Total hours of sleep per day (on postoperative days 1 and 2)
Time Frame
0-48 hours
Title
Patient satisfaction
Description
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time Frame
0-48 hours
Title
Surgeon satisfaction
Description
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time Frame
0-48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine A Salviz, MD,AssocProf
Organizational Affiliation
Study Principal Investigator, Corresponding author
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28027224
Citation
Salviz EA, Sivrikoz N, Ozonur A, Orhan-Sungur M, Savran-Karadeniz M, Altun D, Hocaoglu E, Celet-Ozden B, Tugrul KM. Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anesthesia in Patients Undergoing Reduction Mammaplasty: A Historical Cohort Study. Plast Reconstr Surg. 2017 Jan;139(1):20e-28e. doi: 10.1097/PRS.0000000000002842.
Results Reference
result
PubMed Identifier
22055006
Citation
Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.
Results Reference
result
PubMed Identifier
17023279
Citation
Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
Results Reference
result

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Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

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