SPSIP Block for Pain Control After Breast Reduction Surgery

NCT07657949 | Not Yet Recruiting

• 1 other identifier: 26_06_04_35
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Serratus posterior superior intercostal plane block; Ultrasound-guided regional anesthesia; Reduction mammaplasty; Breast reduction surgery; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption During the First 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.

  From the end of surgery to 24 hours after surgery

Secondary Outcomes (3)

• Resting Pain Score at 6 Hours After Surgery

  6 hours after surgery

• Time to First Rescue Analgesic Requirement

  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

  From the end of surgery to 24 hours after surgery

Study Arms (2)

SPSIP Block Group

EXPERIMENTAL

Participants in this arm will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block after induction of general anesthesia and before surgical local infiltration and skin incision. They will also receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment.

Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block; Other: Standard Perioperative Pain Treatment

Control Group

ACTIVE COMPARATOR

Participants in this arm will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. They will not receive serratus posterior superior intercostal plane block.

Other: Standard Perioperative Pain Treatment

Interventions

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block PROCEDURE

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.

Also known as: SPSIP block

SPSIP Block Group

Standard Perioperative Pain Treatment OTHER

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

Also known as: Standard anesthesia and postoperative analgesia

Control Group; SPSIP Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University Hospital: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58050, Turkey (Türkiye)

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Handan Derebaşınlıoğlu, Associate Professor

  Cumhuriyet University

  STUDY DIRECTOR

Central Study Contacts

Murat Çelik, Assistant Professor

CONTACT

+905546902104; mucetr@gmail.com

Handan Derebaşınlıoğlu, Associate Professor

CONTACT

(0346) 258 00 00; hastane@cumhuriyet.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)