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Serratus Posterior Superior Interfascial Plane Block for Thoracoscopic Surgery

Primary Purpose

Lung 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 Lung Diseases focused on measuring VATS, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-III Scheduled for VATS under general anesthesia Exclusion Criteria: history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, patients who do not accept the procedure

Sites / Locations

  • Istanbul Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

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

Outcomes

Primary Outcome Measures

Opioid consumption (Fentanyl PCA)
The primary aim is to compare postoperative opioid consumption from the PCA device.

Secondary Outcome Measures

Pain scores (Numerical rating scale-NRS)
The secondary aim is to compare NRS at the postoperative 24 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
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.

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
NCT05972122
Brief Title
Serratus Posterior Superior Interfascial Plane Block for Thoracoscopic Surgery
Official Title
The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: 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 30, 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 VATS. 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
Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical procedure for lung surgery in recent years. The advantages of VATS compared to open thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications. Although it is a less painful surgical procedure compared to thoracotomy, severe acute postoperative pain can be observed especially in the first hours after VATS. Thoracic epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used in analgesia after VATS. However, due to the difference in surgical technique and trauma between open surgery and VATS, what should be the gold standard for analgesia after VATS is a matter of debate. It is supported that less invasive analgesic techniques should be applied for minimally invasive surgical procedures, especially due to the difficulty of applying TEA and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line regional technique for VATS surgery. However, it is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and it may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, as insufficient analgesia in the postoperative period may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption. 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. 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 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. There is no randomized study in the literature evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS. In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative analgesia management after VATS. Our primary aim is to compare postoperative opioid consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related side effects (allergic reaction, nausea, vomiting), and dermatome levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
VATS, 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
Placebo 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 intercostal 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. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. 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
Opioid consumption (Fentanyl PCA)
Description
The primary aim is to compare postoperative opioid consumption from the PCA device.
Time Frame
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary Outcome Measure Information:
Title
Pain scores (Numerical rating scale-NRS)
Description
The secondary aim is to compare NRS at the postoperative 24 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
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
Other Pre-specified Outcome Measures:
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
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-III Scheduled for VATS under general anesthesia Exclusion Criteria: history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, patients who do not accept the procedure
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 Thoracoscopic Surgery

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