SPSIP Block for Pain Control After Breast Reduction Surgery

Official title

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

Overview

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

• Procedure Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
  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.
• Other Standard 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.

Primary outcome measures

• Total Opioid Consumption During the First 24 Hours After Surgery [Time frame: From the end of surgery to 24 hours after surgery]

Secondary outcome measures (3)

• Resting Pain Score at 6 Hours After Surgery [Time frame: 6 hours after surgery]
• Time to First Rescue Analgesic Requirement [Time frame: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery]
• Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours [Time frame: From the end of surgery to 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Sivas Cumhuriyet University — Sivas

Publications

• Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348. PMID 38462873
• 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. PMID 36883093
• Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18. PMID 31741068
• Singh NP, Makkar JK, Kuberan A, Guffey R, Uppal V. Efficacy of regional anesthesia techniques for postoperative analgesia in patients undergoing major oncologic breast surgeries: a systematic review and network meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Apr;69(4):527-549. doi: 10.1007/s12630-021-02183-z. Epub 2022 Jan 31. PMID 35102494
• Chadbourne EB, Zhang S, Gordon MJ, Ro EY, Ross SD, Schnur PL, Schneider-Redden PR. Clinical outcomes in reduction mammaplasty: a systematic review and meta-analysis of published studies. Mayo Clin Proc. 2001 May;76(5):503-10. doi: 10.4065/76.5.503. PMID 11357797

Identifiers

NCT: NCT07657949 · 26_06_04_35

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗