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

NCT05332028 | Completed Phase 4

• 1 other identifier: B.30.2.ATA.0.01.00/1/6
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Lymphedema; Anesthesia, Local; Surgery

Keywords

mastectomy; anesthesia; paravertebral block; mid-Point Transverse Process Pleura block; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Fentanyl consumption in the postoperative 24 hours.

Secondary Outcomes (3)

• to compare postoperative pain scores at rest and in motion.

  The first 24 hours after surgery.

• time to the first opioid analgesic request.

  immediately after the surgery.

• the amount of rescue analgesics

  The first 24 hours after surgery.

Study Arms (2)

Group 1: Patients undergoing paravertebral block

EXPERIMENTAL

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.

Drug: bupivacaine; Device: 22 gauge 100 mm needle; Drug: Propofol; Drug: fentanyl

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

ACTIVE COMPARATOR

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.

Drug: bupivacaine; Device: 22 gauge 100 mm needle; Drug: Propofol; Drug: fentanyl

Interventions

bupivacaine DRUG

Block applications

Group 1: Patients undergoing paravertebral block; Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block

22 gauge 100 mm needle DEVICE

Block applications

Also known as: needle

Group 1: Patients undergoing paravertebral block; Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block

Propofol DRUG

Routine general anesthesia protocol

Group 1: Patients undergoing paravertebral block; Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block

fentanyl DRUG

patient-controlled analgesia

Group 1: Patients undergoing paravertebral block; Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: who were scheduled for unilateral simple mastectomy operation due to breast cancer.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Mehmet Aksoy

Erzurum, string:Turkey, 25240, Turkey (Türkiye)

Location

Related Publications (8)

• Waks AG, Winer EP. Breast Cancer Treatment: A Review. JAMA. 2019 Jan 22;321(3):288-300. doi: 10.1001/jama.2018.19323.

  PMID: 30667505 BACKGROUND

• 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.

  PMID: 33812473 BACKGROUND

• 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.

  PMID: 19453965 BACKGROUND

• 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.

  PMID: 33481402 BACKGROUND

• 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.

  PMID: 31280100 BACKGROUND

• 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.

  PMID: 27165206 RESULT

• 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.

  PMID: 26359465 RESULT

• 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.

  PMID: 35848451 DERIVED

MeSH Terms

Conditions

Lymphedema

Interventions

Bupivacaine; Needles; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aysenur DOSTBIL

  Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

• Ilker INCE

  Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

• Erdem KARANENIZ

  Department of General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 18, 2022
• Study Start: March 26, 2020
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)