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Comparison of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block in Breast Cancer Surgery

Primary Purpose

Acute Pain, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus thoracis plane block combined with serratus anterior plane block
Serratus anterior plan block
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Quality of recovery-15, Serratus anterior plan block, Transversus thoracis plan block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: ASA I-II-III BMI 20 to 35 kg / m2 Patients scheduled for breast cancer surgery procedure Exclusion Criteria: Patients with previously known allergies to the drugs to be used in the study, Infection near the puncture site, Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.) Known coagulation disorders, Alcohol and drug use, Disorder of consciousness, Opioid use equal to or greater than 60 mg oral morphine equivalent per day, Patients with pre-existing neuropathic pain, Liver failure, renal failure, cardiac failure Morbid obesity (body mass index [BMI] > 35 kg m-2) Uncontrolled diabetes mellitus Women during pregnancy or breastfeeding Not approving the informed consent form

Sites / Locations

  • Aylin Ceren ŞanlıRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided serratus anterior plane block

Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block

Arm Description

SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl

SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl

Outcomes

Primary Outcome Measures

Quality of recovery-15 (QoR-15) score
Quality of recovery-15 (QoR-15) score at 24 hours after surgery

Secondary Outcome Measures

Postoperative opioid consumption
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0, 2, 6, 12, 24 hours postoperatively.
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Full Information

First Posted
October 8, 2023
Last Updated
October 8, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT06082141
Brief Title
Comparison of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block in Breast Cancer Surgery
Official Title
Comparison of the Effect of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block on the Recovery Quality 15 Score in Breast Cancer Surgery: a Double-blind Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif 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
Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delayed wound healing, prolonged hospital stay, increased opioid use and side effects, and high cost of care. Opioid use remains the mainstay of postoperative analgesia. Opioids, especially morphine, inhibit both cellular and humoral immune functions. This effect may be responsible for the high rates of local recurrence and/or metastasis after surgery. Additionally, studies have shown that perioperative opioid use is associated with social abuse. This demonstrates the importance of reducing perioperative opioid use. Currently, multimodal analgesia based on nerve block is being widely investigated and has shown encouraging clinical results. Numerous regional analgesic techniques have been investigated in breast cancer surgery, including intercostal nerve block, thoracic epidural anesthesia, and paravertebral block. Compared with general anesthesia alone, it reduces the postoperative pain score even after a single-shot injection for up to 72 hours, reduces opioid consumption, improves the quality of patient recovery, and suppresses the development or reduces the severity of chronic pain. Serratus anterior plane block (SAPB) is reported to be effective in perioperative pain management of breast cancer surgeries. The important problem of SAPB block is that it is insufficient to block the anterior cutaneous branches of the intercostal nerves. Therefore, intravenous analgesia is required. Thoracic transversus muscle plane block (TTPB) is a recently described fascial plane block used to anesthetize the anterior cutaneous branches of the intercostal nerves from T2-T6. Its effectiveness has been demonstrated for breast surgery and median sternotomy. In our study, we will provide postoperative analgesia in patients undergoing breast surgery by applying the serratus anterior block in combination with the transversus thoracis plane block. Since we avoid complicated analgesia methods such as paravertebral block, the risk of complications will be reduced. In this study, we aimed to compare the effectiveness of the combination of SAPB and TTPB with SAPB performed alone in breast cancer surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Opioid Use
Keywords
Quality of recovery-15, Serratus anterior plan block, Transversus thoracis plan block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided serratus anterior plane block
Arm Type
Active Comparator
Arm Description
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl
Arm Title
Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block
Arm Type
Active Comparator
Arm Description
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl
Intervention Type
Procedure
Intervention Name(s)
Transversus thoracis plane block combined with serratus anterior plane block
Intervention Description
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl under US-guidance
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plan block
Intervention Description
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 10 ml NaCl under US-guidance
Primary Outcome Measure Information:
Title
Quality of recovery-15 (QoR-15) score
Description
Quality of recovery-15 (QoR-15) score at 24 hours after surgery
Time Frame
at the end of 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Time Frame
up to the first 24 hours postoperatively
Title
Pain intensity score
Description
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0, 2, 6, 12, 24 hours postoperatively.
Time Frame
0, 2, 6, 12, 24 hours postoperatively.
Title
Postoperative nausea and vomiting
Description
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Time Frame
up to the first 24 hours postoperatively
Title
Patient satisfaction
Description
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time Frame
at the end of 24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II-III BMI 20 to 35 kg / m2 Patients scheduled for breast cancer surgery procedure Exclusion Criteria: Patients with previously known allergies to the drugs to be used in the study, Infection near the puncture site, Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.) Known coagulation disorders, Alcohol and drug use, Disorder of consciousness, Opioid use equal to or greater than 60 mg oral morphine equivalent per day, Patients with pre-existing neuropathic pain, Liver failure, renal failure, cardiac failure Morbid obesity (body mass index [BMI] > 35 kg m-2) Uncontrolled diabetes mellitus Women during pregnancy or breastfeeding Not approving the informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aylin Ceren Sanli, Asist Dr
Phone
+0905496522412
Email
asanli@bezmialem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Sanli
Facility Information:
Facility Name
Aylin Ceren Şanlı
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aylin Ceren Sanli, Asist Dr
First Name & Middle Initial & Last Name & Degree
Aylin Ceren Sanli, Asist Dr
Phone
+0905496522412
Email
asanli@bezmialem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Serratus Anterior Plane Block and the Combination of Serratus Anterior Plane Block and Transversus Thoracis Plane Block in Breast Cancer Surgery

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