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SPSIP Block for Pain Control After Breast Reduction Surgery

Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07657949
Acronym
SPSIP-RM
Enrollment
80
Registered
2026-06-18
Start date
2026-08-24
Completion date
2027-09-30
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Mammaplasty, Nerve Block, Opioid Consumption, Postoperative, Postoperative Pain Breast Reduction

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.

OTHERStandard Perioperative Pain Treatment

Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.

Sponsors

Cumhuriyet University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Total Opioid Consumption During the First 24 Hours After SurgeryFrom the end of surgery to 24 hours after surgeryTotal 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

MeasureTime frameDescription
Resting Pain Score at 6 Hours After Surgery6 hours after surgeryPain 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 RequirementFrom the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgeryThe 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 HoursFrom the end of surgery to 24 hours after surgeryThe 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

CONTACTMurat Çelik, Assistant Professor
mucetr@gmail.com+905546902104
CONTACTHandan Derebaşınlıoğlu, Associate Professor
hastane@cumhuriyet.edu.tr(0346) 258 00 00
STUDY_DIRECTORHandan Derebaşınlıoğlu, Associate Professor

Cumhuriyet University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026