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Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery

Primary Purpose

Mastectomy; Lymphedema, Anesthesia, Local, Surgery

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
bupivacaine
22 gauge 100 mm needle
Propofol
fentanyl
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema focused on measuring mastectomy, anesthesia, paravertebral block, mid-Point Transverse Process Pleura block, patient-controlled analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients were informed about the study, and written informed consent was obtained from all participants who agreed to participate in the study.
  • aged 18-65 years
  • ASA I-III
  • scheduled for unilateral simple mastectomy operation due to breast cancer.

Exclusion Criteria:

  • ASA >3
  • BMI≥35
  • bleeding diathesis
  • neurological disease
  • infections at the needle site
  • a history of allergy to any of the drugs used in the study
  • those who had undergone axillary lymph dissection

Sites / Locations

  • Mehmet Aksoy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Patients undergoing paravertebral block

Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block

Arm Description

After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.

After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.

Outcomes

Primary Outcome Measures

to compare the postoperative opioid consumption in the first 24 hours after surgery
All of the patients were extubated and taken to the postaesthetic care unit (PACU).In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered.

Secondary Outcome Measures

to compare postoperative pain scores at rest and in motion.
Postoperative pain was assessed using VAS, which ranged from 0 (no pain) to 10 (worst imaginable pain).
time to the first opioid analgesic request.
Postoperative follow-up of the cases was done by an independent observer.
the amount of rescue analgesics
Patients with a VAS score of 4 and above received rescue analgesic.

Full Information

First Posted
April 2, 2022
Last Updated
April 14, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05332028
Brief Title
Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery
Official Title
Comparison of the Analgesic Efficacy of Ultrasound-guided Paravertebral Block and Mid-point Transverse Process Pleura Block in Mastectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk 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 was performed to analyze the postoperative analgesic effects of the paravertebral block (PVB) and Mid-Point Transverse Process Pleura (MTP) block after a unilateral mastectomy surgery. This study included 64 women aged 18-65 years, American Society of Anesthesiologists score I-III, who were scheduled for unilateral simple mastectomy operation due to breast cancer. Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes. Patients were placed in the prone position. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level in Group 1, and the midpoint level between the transverse process and pleura in Group 2, it was observed that there was no blood or air by aspiration. Then, the needle location was confirmed with 0.5-1 mL of saline, and a 20 mL of 0.25% bupivacaine was applied. Thirty minutes after block application, the sensorial block level was evaluated by pinprick test at the midclavicular line, and the blocked dermatome area was recorded as front and back. Complications developed during the process (such as hypotension, vascular injury, local anaesthetic toxicity) were recorded.Routine general anesthesia protocol was performed to all patients.At the end of the surgery, neuromuscular block antagonization was performed with 4 mg/kg sugammadex. All of the patients were extubated and taken to the postanesthetic care unit (PACU). In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered. Time to the first request for analgesia, postoperative fentanyl consumption, and VAS score values at rest and in motion at postoperative 1, 4, 8, 12, 16, 20 and 24 hours, the duration of block implementation and the duration of surgery were recorded.
Detailed Description
This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of the paravertebral block (PVB) and Mid-Point Transverse Process Pleura (MTP) block after a unilateral mastectomy surgery. This prospective randomized placebo-controlled triple-blind study was approved by the Ethical Committee of Ataturk University, Medical Faculty, Erzurum, Turkey. The study was carried out at the Anesthesiology and Reanimation Department of Ataturk University, Medical Faculty, Erzurum, Turkey.This study included 64 women aged 18-65 years, American Society of Anesthesiologists score I-III, who were scheduled for unilateral simple mastectomy operation due to breast cancer.The day before surgery, patients were assessed by a researcher who was blind to group assignment. All patients were informed about the study, and written informed consent was obtained from all participants who agreed to participate in the study. This study was planned as triple-blind; patients and investigators were blinded to the group allocation. The patients were fasted for 8 hours before surgery. Before the anesthesia procedure, demographic data of all patients (age, weight, height, ASA physical status), baseline values of heart rate, systolic, diastolic and average blood pressure were recorded. Vascular access was established for all patients via 22-gauge intravenous cannula, and premedication was provided using 0.03 mg/kg of IV midazolam. Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes. An investigator opened the sealed opaque envelopes before the block application. An another anesthetist who was blinded to the group assignment was responsible for collecting intra-and postoperative data. All surgeries were done by the same surgical and anaesthetic teams. All blocks were fulfilled by the same anesthesiologist, who had at least five years of experience in the profession, with the help of a flat probe (1-8 MHz) and using 22 gauge, 100 mm insulated facet tip needles before general anesthesia. Patients were placed in a sitting position, spinous processes were marked starting from the C7 spinous process to the T6 level. Then, patients were placed in the prone position. After cleaning the area with antiseptic solution, the sterilized linear ultrasonography probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level in Group 1, and the midpoint level between the transverse process and pleura in Group 2, it was observed that there was no blood or air by aspiration. Then, the needle location was confirmed with 0.5-1 mL of saline, and a 20 mL of 0.25% bupivacaine was applied. Local anesthetic dissemination was seen in both cranial and caudal directions. Thirty minutes after block application, the sensorial block level was evaluated by pinprick test (normal sensation:0, decreased sensation:1, insensitivity:2) at the midclavicular line, and the blocked dermatome area was recorded as front and back. The duration from placing the patient in the prone position to removing the needle used for the block procedure was defined as the block application duration and recorded. Complications developed during the process (such as hypotension, vascular injury, local anesthetic toxicity) were recorded. Routine general anesthesia protocol was performed using 2-3 mg/kg IV propofol, 2 µg/kg IV fentanyl and 0.6 mg/kg IV rocuronium. Anesthesia was maintained with desflurane, a fresh gas flow of 3 L/min and a nitrous oxide mixed with oxygen in a 2:1 ratio. During surgery, the patients' systolic, diastolic and average artery blood pressures and oxygen saturation values were recorded in the 5th, 10th, 15th, 20th, 35th, and 50th minutes, and postoperative 1st and 2nd hours. All operations were performed by the same surgical team using the same surgical technique. At the end of the surgery, neuromuscular block antagonization was performed with 4 mg/kg sugammadex. All of the patients were extubated and taken to the postanesthetic care unit (PACU). Patients with a modified Aldrete score of 9 and above were transferred to the clinic. At the end of the surgery, IV 1g of paracetamol was administered to all patients. The same dose was repeated every 6 hours postoperatively. To prevent postoperative nausea and vomiting, IV 8 mg of ondansetron was administered to all patients. Intravenous ephedrine (6 mg) was used to treat hypotension (a 20% decrease in systolic blood pressure compared to preoperative values) and IV atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery. When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered. In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered. The PCA was set at a 10 μg/mL concentration, with a 50 μg loading dose, 10 minutes lockout duration, a bolus of 25 μg, and without basal infusion, and it was left connected for 24 hours. Postoperative fentanyl consumption was recorded as 0-4 hours, 4-8 hours, 8-12 hours, 12-16 hours, 16-20 hours, 20-24 hours and 24 hours total. A patient-controlled analgesia device (PCA), which contains fentanyl at a concentration of 10 mcg/ml, with a loading dose of 50mcg, a lock-out duration of 10 minutes, a bolus dose of 25 mcg, and no basal infusion, was connected to all patients in the PACU. Postoperative pain was assessed using Visual Analog Pain Scale (VAS), which ranged from 0 (no pain) to 10 (worst imaginable pain) in the postoperative 1, 4, 8, 12, 16, 20 and 24th hours. Patients with a VAS score of 4 and above received 25 mg of rescue meperidine. The incidence of nausea and vomiting was recorded in the postoperative first 24 hours. Postoperative follow-up of the cases was done by an independent observer who was blinded to the group assignment. Time to the first request for analgesia, postoperative fentanyl consumption, and VAS score values at rest and in motion at postoperative 1, 4, 8, 12, 16, 20 and 24 hours, the duration of block implementation and the duration of surgery were recorded. Power analysis for the study was calculated using the NCSS-PASS (NCSS LLC, Kaysville, Utah) software. The primary end point of the study was the total opioid consumption for the first 24 hours postoperatively. The minimum sample size required for this study was calculated based on Gürkan et al.'s study. They reported that the difference between groups opioid requirements in the first 24 hours after surgery was 1.5; the common standard deviation within a group was assumed to be 3.43 and 4.15. As a result of a power analysis, the sample size for a group was determined to be 30 patients with a power of 80% and alpha of 5%. It was planned to include 64 patients throughout the study, 32 patients in each group, considering potential dropouts. The SPSS 20 package software was used for data analysis. Numerical data were expressed as mean and standard deviation, categorical data were presented as numbers (n) and percentages (%). The normal distribution of data were evaluated using a the Kolmogorov-Smirnov Z test. Independent sample t-test was used for the analysis of parametric data and Mann-Whitney U test was used for the analysis of non-parametric data. Analysis of repetitive measurements in intra-group comparisons was done with ANOVA, analysis of categorical data was done using chi-square test. The results were considered statistically significant if p value<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema, Anesthesia, Local, Surgery
Keywords
mastectomy, anesthesia, paravertebral block, mid-Point Transverse Process Pleura block, patient-controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes. An investigator opened the sealed opaque envelopes before the block application.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study was planned as triple-blind; patients and investigators were blinded to the group allocation. An investigator opened the sealed opaque envelopes before the block application. An another anaesthetist who was blinded to the group assignment was responsible for collecting intra-and postoperative data.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Patients undergoing paravertebral block
Arm Type
Experimental
Arm Description
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Arm Title
Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block
Arm Type
Active Comparator
Arm Description
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
Block applications
Intervention Type
Device
Intervention Name(s)
22 gauge 100 mm needle
Other Intervention Name(s)
needle
Intervention Description
Block applications
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Routine general anesthesia protocol
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
patient-controlled analgesia
Primary Outcome Measure Information:
Title
to compare the postoperative opioid consumption in the first 24 hours after surgery
Description
All of the patients were extubated and taken to the postaesthetic care unit (PACU).In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered.
Time Frame
Fentanyl consumption in the postoperative 24 hours.
Secondary Outcome Measure Information:
Title
to compare postoperative pain scores at rest and in motion.
Description
Postoperative pain was assessed using VAS, which ranged from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
The first 24 hours after surgery.
Title
time to the first opioid analgesic request.
Description
Postoperative follow-up of the cases was done by an independent observer.
Time Frame
immediately after the surgery.
Title
the amount of rescue analgesics
Description
Patients with a VAS score of 4 and above received rescue analgesic.
Time Frame
The first 24 hours after surgery.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
who were scheduled for unilateral simple mastectomy operation due to breast cancer.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients were informed about the study, and written informed consent was obtained from all participants who agreed to participate in the study. aged 18-65 years ASA I-III scheduled for unilateral simple mastectomy operation due to breast cancer. Exclusion Criteria: ASA >3 BMI≥35 bleeding diathesis neurological disease infections at the needle site a history of allergy to any of the drugs used in the study those who had undergone axillary lymph dissection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur DOSTBIL
Organizational Affiliation
Department of Anesthesiology and Reanimation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilker INCE
Organizational Affiliation
Department of Anesthesiology and Reanimation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erdem KARANENIZ
Organizational Affiliation
Department of General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mehmet Aksoy
City
Erzurum
State/Province
string:Turkey
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
participants do not allow data to be shared.
Citations:
PubMed Identifier
30667505
Citation
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Results Reference
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Citation
Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1. Erratum In: Lancet. 2021 May 8;397(10286):1710.
Results Reference
background
PubMed Identifier
19453965
Citation
Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
Results Reference
background
PubMed Identifier
33481402
Citation
Lam S, Qu H, Hannum M, Tan KS, Afonso A, Tokita HK, McCormick PJ. Trends in Peripheral Nerve Block Usage in Mastectomy and Lumpectomy: Analysis of a National Database From 2010 to 2018. Anesth Analg. 2021 Jul 1;133(1):32-40. doi: 10.1213/ANE.0000000000005368.
Results Reference
background
PubMed Identifier
31280100
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
Results Reference
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PubMed Identifier
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Citation
Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016;17(S3):43-6. doi: 10.7314/apjcp.2016.17.s3.43.
Results Reference
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PubMed Identifier
26359465
Citation
DeSantis CE, Bray F, Ferlay J, Lortet-Tieulent J, Anderson BO, Jemal A. International Variation in Female Breast Cancer Incidence and Mortality Rates. Cancer Epidemiol Biomarkers Prev. 2015 Oct;24(10):1495-506. doi: 10.1158/1055-9965.EPI-15-0535. Epub 2015 Sep 10.
Results Reference
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Citation
Kahramanlar AA, Aksoy M, Ince I, Dostbil A, Karadeniz E. The Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Paravertebral Block and Mid-Point Transverse Process Pleura Block in Mastectomy Surgeries: A Randomized Study. J Invest Surg. 2022 Sep;35(9):1694-1699. doi: 10.1080/08941939.2022.2098544. Epub 2022 Jul 17.
Results Reference
derived

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Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery

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