Serratus Posterior Superior Interfascial Plane Block for Breast Surgery

Sponsor

Medipol University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972083

Collaborator

(none)

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

16.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases	Drug: Analgesia management; group S and C	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two models for this study. The first group is the SPSIPB group. The second one is the control group.There are two models for this study. The first group is the SPSIPB group. The second one is the control group.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 3, 2023

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Nov 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group S = SPSIPB group 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.	Drug: Analgesia management; group S and C 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.
Other: Group C = Control group The wound infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.	Drug: Analgesia management; group S and C 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.

Arm

Intervention/Treatment

Active Comparator: Group S = SPSIPB group

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.

Drug: Analgesia management; group S and C

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.

Other: Group C = Control group

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

Drug: Analgesia management; group S and C

Outcome Measures

Primary Outcome Measures

Pain scores (Numerical rating scale-NRS) [Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours]
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) [Postoperative 24 hours period]
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Adverse events [Postoperative 24 hours period]
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Dermatomal analyses [Postoperative 1st hour]
The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University Hospital	Istanbul	Bagcilar	Turkey	34070

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bahadir Ciftci, Primary researcher, Medipol University

ClinicalTrials.gov Identifier:

NCT05972083

Other Study ID Numbers:

Medipol Hospital 33

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University

Mastectomy and axillary dissection surgery

Postoperative pain management

Serratus Posterior Superior Interfascial Plane Block

Additional relevant MeSH terms:

Breast Diseases

Study Results

No Results Posted as of Aug 2, 2023