Trial Title:
Comparison of ESP and SPSIP Blocks in Breast Surgery
NCT ID:
NCT06611644
Condition:
Breast Surgery
Macromastia
Mammaplasty
Modified Radical Mastectomy
Mammary Cancer
Breast Implant
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Pain Management
Regional Anesthesia
Multimodal Treatment
Modified Radical Mastectomy
Mammaplasty
Breast Implants
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study consists of three groups: a Control Group receiving standard postoperative
pain management, an ESP Block Group receiving an Erector Spinae Plane (ESP) block, and an
SPSIP Block Group receiving a Serratus Posterior Superior Intercostal Plane (SPSIP)
block, all aimed at comparing the efficacy of these methods in managing postoperative
pain.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
The study will be conducted in a double-blind design. Neither the patients nor the
researchers assessing pain management will know which treatment has been applied. The
anesthesia team, present in the operating room and responsible for administering the
blocks, will be aware of the group assignments, but the research team responsible for
postoperative evaluations will not have access to this information. The operating room
coordinator will assign each patient to the appropriate group according to a
randomization list and will only share this information with the anesthesia team. The
research team evaluating postoperative pain scores and collecting data will do so without
knowledge of the patients' treatment group, ensuring objectivity in the assessments
through blinding.
Intervention:
Intervention type:
Other
Intervention name:
Erector Spinae Plane Block
Description:
Patients in this group will receive an Erector Spinae Plane (ESP) block in addition to
standard postoperative care. The ESP block will be performed under ultrasound guidance. A
needle will be advanced in-plane or out-of-plane, targeting the lateral aspect of the T6
transverse process. Local anesthetic (20 to 30 ml) will be injected into the fascial
plane between the erector spinae muscle and the transverse process. This block is
intended to provide postoperative analgesia by blocking the transmission of pain through
the thoracic spinal nerves.
Arm group label:
Erector Spinae Plane (ESP) block group
Intervention type:
Other
Intervention name:
SPSIPB blcok
Description:
Patients in this group will receive a Serratus Posterior Superior Intercostal Plane
(SPSIP) block along with standard postoperative care. The SPSIP block will be performed
under ultrasound guidance, where the needle is advanced between the second and third ribs
towards the medial aspect of the scapula. Local anesthetic 20 to 30 ml) will be injected
into the fascial plane between the serratus posterior superior muscle and the intercostal
muscles after confirming needle placement with hydrodissection using 1-2 ml of saline.
This block is intended to provide broad analgesia across the upper thoracic dermatomes,
from C3 to T7, to control postoperative pain.
Arm group label:
Serratus Posterior Superior Intercostal Plane (SPSIP) block
Intervention type:
Other
Intervention name:
Control
Description:
Patients in the control group will receive standard postoperative pain management without
any regional block intervention. This will include the administration of systemic
analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs). Opioid
analgesics will be administered as needed based on the patient's pain level. Pain
management will be conducted according to the standard protocol followed for breast
surgery patients.
Arm group label:
Control Group
Summary:
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing
postoperative pain following breast surgery. Breast surgery, particularly after
oncological and reconstructive procedures, often leads to significant postoperative pain.
Effective pain control is crucial for accelerating recovery, reducing the risk of
complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the
administration of local anesthetics into fascial plane spaces to achieve peripheral nerve
blockade and control pain. This study will evaluate the effectiveness of these blocks in
terms of pain scores, opioid consumption, and overall patient satisfaction to determine
the optimal approach for postoperative pain management in breast surgery.
Detailed description:
Breast surgery is one of the most frequently performed procedures, and effective
postoperative pain management is critical to its success. Proper pain control not only
facilitates early mobilization but also reduces the risks of pulmonary complications,
deep vein thrombosis, and embolism. It helps prevent stress-induced endocrine and
metabolic responses, shortens hospital stays, and lowers healthcare costs. Regional
anesthesia is a highly effective strategy for postoperative pain control, minimizing
opioid use and its associated side effects such as sedation, nausea, vomiting, and
constipation.
Among the commonly used regional anesthesia techniques in breast surgery are the Erector
Spinae Plane (ESP) block, Serratus Anterior Plane block, and Pectoral block. While the
ESP block appears more effective, conflicting evidence exists regarding its efficacy in
postoperative pain management, with variability in block spread across individuals. The
recently introduced Serratus Posterior Superior Intercostal Plane (SPSIP) block, a
periparavertebral block, offers a wider distribution range from C3 to T7 dermatomes,
suggesting potential for more comprehensive postoperative analgesia in breast procedures.
The ESP block is performed under ultrasound guidance, using an in-plane technique to
advance the needle from caudal to cranial (or vice versa), targeting the lateral part of
the T6 transverse process, where local anesthetic is injected between the erector spinae
muscle and the transverse process. For the SPSIP block, the needle is advanced between
the second and third ribs towards the medial scapula, reaching the fascial plane between
the serratus posterior superior muscle and the intercostal muscles. After hydrodissection
confirms placement, local anesthetic is injected.
This study aims to compare the efficacy of ESP and SPSIP blocks in managing postoperative
pain in breast surgery by evaluating pain scores, opioid consumption, and patient
satisfaction. Since no study has yet directly compared these blocks, the findings will
make a significant contribution to the existing literature.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Age between 18 and 65 years.
- Scheduled for breast surgery (Modified Radical Mastectomy with or without axillary
lymph node dissection, Mastopexy, Reduction Mammoplasty).
- Preoperative anesthesia risk classified as ASA I-III according to the American
-Society of Anesthesiologists (ASA) classification.
- Patients who provide informed consent for participation in the study.
Exclusion Criteria
- History of coagulation disorders.
- Patients using aspirin or medically prescribed anticoagulants.
- Patients with severe systemic diseases (ASA IV).
- Patients undergoing emergency surgery.
- Patients younger than 18 or older than 65 years.
- Patients who do not develop adequate sensory block after the procedure.
- Presence of infection at the block site.
- Patients with thoracic deformities.
- Patients who decline to participate in the study.
Gender:
Female
Gender based:
Yes
Gender description:
Only individuals as female will be eligible to participate in this study, as the focus is
on breast surgeries, which are performed on female patients.
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Canakkale Onsekiz Mart University
Address:
City:
Canakkale
Zip:
17020
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mihrican Sayan, M.D.
Phone:
+905348678180
Email:
mihricaneren1@gmail.com
Start date:
July 6, 2024
Completion date:
January 16, 2025
Lead sponsor:
Agency:
Çanakkale Onsekiz Mart University
Agency class:
Other
Source:
Çanakkale Onsekiz Mart University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611644
