Analgesia, Mammaplasty, Nerve Block, Opioid Consumption, Postoperative, Postoperative Pain Breast Reduction
Conditions
Keywords
Serratus posterior superior intercostal plane block, Ultrasound-guided regional anesthesia, Reduction mammaplasty, Breast reduction surgery, Postoperative pain
Brief summary
The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery. The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block. Participants will: * Have planned bilateral breast reduction surgery under general anesthesia * Be randomly assigned to the SPSIP block group or the control group * Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery * Have their pain score and pain medicine use recorded during the first 24 hours after surgery * Be followed for safety and complications for 30 days after surgery
Detailed description
Reduction mammaplasty, also known as breast reduction surgery, may be associated with early postoperative pain because it is usually performed bilaterally and involves wide surgical dissection and tissue resection. Multimodal pain treatment is commonly used after this procedure to provide adequate pain control and to limit opioid exposure. The serratus posterior superior intercostal plane block (SPSIP block) is an ultrasound-guided fascial plane block used for thoracic wall analgesia. Recent studies have evaluated this block in breast surgery, but data specific to reduction mammaplasty remain limited. In routine practice, surgical local anesthetic infiltration is often used during reduction mammaplasty. Therefore, this trial will evaluate whether adding bilateral SPSIP block to standard anesthesia, surgical local infiltration, and standard postoperative pain treatment provides additional opioid-sparing benefit. This study is designed as a prospective, randomized, parallel-group, assessor-blinded, single-center clinical trial. Participants scheduled for elective bilateral reduction mammaplasty will be assigned in a 1:1 ratio to either the SPSIP block group or the control group. In the SPSIP block group, bilateral SPSIP block will be performed under ultrasound guidance after induction of general anesthesia and before surgical local infiltration and skin incision. The control group will not receive SPSIP block. Both groups will receive the same standardized general anesthesia, surgical local anesthetic infiltration, postoperative multimodal analgesia, and rescue analgesia protocol. The local anesthetic agent, concentration, volume, and maximum safe dose limits for the block and surgical infiltration will be standardized before study enrollment. The trial is planned to reflect routine plastic surgery practice. Surgical technique, pedicle selection, resection amount, drain use, and the use of dermal graft or internal support when clinically needed will be decided by the surgical team according to participant anatomy and routine clinical judgment. These variables will be recorded to describe surgical variability and may be considered in additional analyses if needed. Postoperative pain assessments will be performed by ward nurses who are blinded to group allocation. Opioid use will be obtained from medication administration records. Block-related events and surgical complications will be recorded during routine postoperative care and up to 30 days after surgery.
Interventions
Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed after induction of general anesthesia and before surgical local anesthetic infiltration and skin incision.
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Sponsors
Study design
Masking description
Participants will receive the intervention under general anesthesia and will not be informed of their group allocation during postoperative assessment. Postoperative pain scores and early clinical outcomes will be recorded by ward nurses who are blinded to group allocation. The anesthesia team performing the block will not be masked.
Intervention model description
Participants will be randomized in a 1:1 ratio to two parallel groups: the SPSIP block group and the control group. The SPSIP block group will receive bilateral ultrasound-guided SPSIP block in addition to standard anesthesia and postoperative pain treatment. The control group will receive standard anesthesia and postoperative pain treatment without SPSIP block.
Eligibility
Inclusion criteria
* Female participants aged 18 to 65 years * Scheduled for elective bilateral reduction mammaplasty * Planned surgery under general anesthesia * American Society of Anesthesiologists physical status class I to III * Planned postoperative clinical follow-up for the first 24 hours after surgery * Able to understand and report pain using the 0 to 10 Numeric Rating Scale * Able to provide written informed consent for study participation
Exclusion criteria
* Known allergy or hypersensitivity to local anesthetic drugs * Contraindication to regional anesthesia or fascial plane block * Coagulopathy or clinically significant bleeding disorder * Use of anticoagulant or antiplatelet medication that prevents safe block application * Infection at the planned block injection site * Chronic opioid use, chronic pain syndrome, or regular analgesic use that may affect postoperative pain assessment * Revision breast surgery * Planned major additional surgical procedure other than reduction mammaplasty * Pregnancy or lactation * Unable to reliably report pain scores
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption During the First 24 Hours After Surgery | From the end of surgery to 24 hours after surgery | Total opioid consumption will be calculated from all rescue opioid analgesics administered during the first 24 hours after surgery. Opioid use will be obtained from medication administration records and reported as intravenous morphine equivalent dose in milligrams. Higher values indicate greater opioid consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Pain Score at 6 Hours After Surgery | 6 hours after surgery | Pain intensity at rest will be assessed using the 0 to 10 Numeric Rating Scale. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. |
| Time to First Rescue Analgesic Requirement | From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery | The time from the end of surgery to the first administration of rescue analgesic medication will be recorded. Longer time indicates longer duration before additional analgesic treatment is needed. |
| Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours | From the end of surgery to 24 hours after surgery | The number of participants who develop postoperative nausea, vomiting, or require additional antiemetic medication during the first 24 hours after surgery will be recorded. This outcome will be assessed as present or absent for each participant. |
Countries
Turkey (Türkiye)
Contacts
Cumhuriyet University