SPSIP Block for Pain Control After Breast Reduction Surgery (SPSIP-RM)
Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Murat Çelik, Assistant Professor
- Número de teléfono: +905546902104
- Correo electrónico: mucetr@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Handan Derebaşınlıoğlu, Associate Professor
- Número de teléfono: (0346) 258 00 00
- Correo electrónico: hastane@cumhuriyet.edu.tr
Ubicaciones de estudio
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Sivas
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Sivas, Sivas, Turquía (Türkiye), 58050
- Reclutamiento
- Sivas Cumhuriyet University
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Investigador principal:
- Murat Çelik, Assistant Professor
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Sub-Investigador:
- Handan Derebaşınlıoğlu, Associate Professor
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Contacto:
- Murat Çelik
- Número de teléfono: 05546902104
- Correo electrónico: mucetr@gmail.com
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Contacto:
- Onur Avcı, Associate Professor
- Número de teléfono: 90 530 112 64 08
- Correo electrónico: dronuravci@gmail.com
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Sub-Investigador:
- Onur Avcı, Associate Professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: SPSIP Block Group
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.
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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.
Otros nombres:
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Otros nombres:
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Comparador activo: Control Group
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.
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Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Opioid Consumption During the First 24 Hours After Surgery
Periodo de tiempo: From the end of surgery to 24 hours after surgery
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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.
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From the end of surgery to 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Resting Pain Score at 6 Hours After Surgery
Periodo de tiempo: 6 hours after surgery
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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.
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6 hours after surgery
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Time to First Rescue Analgesic Requirement
Periodo de tiempo: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
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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.
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From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
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Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
Periodo de tiempo: From the end of surgery to 24 hours after surgery
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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.
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From the end of surgery to 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26_06_04_35
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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