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Serratus Posterior Superior Interfascial Plane Block for Breast Surgery

Primary Purpose

Breast Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Analgesia management; group S and C
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Diseases focused on measuring Mastectomy and axillary dissection surgery, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block

Eligibility Criteria

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

Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for mastectomy and axillary dissection surgery under general anesthesia Exclusion Criteria: receiving anticoagulant treatment, known study drugs allergy, opioid addiction infection of the skin at the site of the block, pregnancy or lactation,

Sites / Locations

  • Istanbul Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Group S = SPSIPB group

Group C = Control group

Arm Description

A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.

The wound infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.

Outcomes

Primary Outcome Measures

Pain scores (Numerical rating scale-NRS)
The primary aim is to compare NRS at the postoperative 1st h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded

Secondary Outcome Measures

Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Dermatomal analyses
The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.

Full Information

First Posted
July 25, 2023
Last Updated
August 9, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05972083
Brief Title
Serratus Posterior Superior Interfascial Plane Block for Breast Surgery
Official Title
The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Pain Control in Female Patients Underwent Mastectomy and Axillary Lymph Node Dissection: A Randomized, Prospective, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol 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
Regional techniques can be used for postoperative pain control following breast surgery. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
Detailed Description
Mastectomy and axillary lymph node dissection are among the most frequently performed surgeries today, and pain control is an important problem affecting patient comfort in the postoperative period in these patients. Postoperative pain is an acute pain associated with the inflammatory process that occurs due to surgical trauma and gradually decreases with tissue healing. Several analgesic drugs such as opioids are used to prevent this pain, but these agents have many unwanted side effects. Successful postoperative analgesia occurs in the patient due to pain; it is a known fact that it prevents many of the effects such as not being able to breathe easily and delayed mobilization. Regional techniques can be used for postoperative pain control following breast surgery. Ultrasound (US) guided serratus posterior superior block (SPSIPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided. In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were clearly stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. In this study, our aim is to investigate the efficacy of US-guided SPSIPB for postoperative analgesia management after mastectomy and axillary lymph node dissection surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate the need for rescue analgesics, block-related complications, dermatome level, and side effects (allergic reaction, nausea, vomiting) associated with opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
Mastectomy and axillary dissection surgery, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is the SPSIPB group. The second one is the control group.
Masking
ParticipantOutcomes Assessor
Masking Description
The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group S = SPSIPB group
Arm Type
Active Comparator
Arm Description
A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
Arm Title
Group C = Control group
Arm Type
Other
Arm Description
The wound infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.
Intervention Type
Drug
Intervention Name(s)
Analgesia management; group S and C
Intervention Description
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Primary Outcome Measure Information:
Title
Pain scores (Numerical rating scale-NRS)
Description
The primary aim is to compare NRS at the postoperative 1st h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Time Frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
Secondary Outcome Measure Information:
Title
Need for rescue analgesia (meperidine)
Description
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Time Frame
Postoperative 24 hours period
Title
Adverse events
Description
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Time Frame
Postoperative 24 hours period
Title
Dermatomal analyses
Description
The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.
Time Frame
Postoperative 1st hour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients who will undergo breast surgery will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for mastectomy and axillary dissection surgery under general anesthesia Exclusion Criteria: receiving anticoagulant treatment, known study drugs allergy, opioid addiction infection of the skin at the site of the block, pregnancy or lactation,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahadır Çiftçi, Assoc prof, MD
Phone
05343736865
Email
bciftci@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Selçuk Alver, Assist prof, MD
Email
selcukalver@yahoo.com
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, MD
Phone
+905325034428
Email
bciftci@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
36883093
Citation
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
Results Reference
background
PubMed Identifier
37272274
Citation
Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Jun 1. doi: 10.23736/S0375-9393.23.17432-3. Online ahead of print. No abstract available.
Results Reference
background

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Serratus Posterior Superior Interfascial Plane Block for Breast Surgery

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