NCT07502846

Brief Summary

The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the mid-axillary line, targeting the lateral cutaneous branches of the intercostal nerves and providing analgesia to the anterolateral thoracic wall. The present prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic efficacy of superficial and deep SAPB techniques in patients undergoing mammoplasty surgery. The primary objective is to evaluate total opioid consumption within the first 24 hours postoperatively,while secondary outcomes include postoperative pain scores,additional analgesic requirements, postoperative nausea and vomiting, patient satisfaction, time to first mobilization, and vital signs within the first 24 hours postoperatively. The results of this study may help determine the more effective SAPB technique for improving postoperative pain control and reducing opioid use in patients undergoing mammoplasty.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 14, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Serratus Anterior Plane BlockSAPBMammoplastyBreast SurgeryPostoperative AnalgesiaPostoperative PainOpioid Consumption

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Total opioid consumption required for postoperative analgesia in patients undergoing mammoplasty surgery.

    Within the first 24 hours postoperatively

Secondary Outcomes (9)

  • Postoperative pain score (Numeric Rating Scale)

    Within the first 24 hours postoperatively

  • Additional analgesic requirement

    Within the first 24 hours postoperatively

  • Postoperative nausea and vomiting

    Within the first 24 hours postoperatively

  • Patient satisfaction score and Quality of Recovery Score (QoR-15)

    Within the first 24 hours postoperatively

  • Time to first mobilization

    Within the first 24 hours postoperatively

  • +4 more secondary outcomes

Study Arms (2)

Superficial Serratus Anterior Plane Block

EXPERIMENTAL

Patients undergoing mammoplasty surgery who receive an ultrasound-guided superficial serratus anterior plane block for postoperative analgesia.

Procedure: Superficial Serratus Anterior Plane Block

Deep Serratus Anterior Plane Block

EXPERIMENTAL

Patients undergoing mammoplasty surgery who receive an ultrasound-guided deep serratus anterior plane block for postoperative analgesia.

Procedure: Deep Serratus Anterior Plane Block

Interventions

Ultrasound-guided superficial serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the latissimus dorsi and serratus anterior muscles to provide postoperative analgesia in patients undergoing mammoplasty surgery.

Superficial Serratus Anterior Plane Block

Ultrasound-guided deep serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the serratus anterior muscle and the ribs to provide postoperative analgesia in patients undergoing mammoplasty surgery.

Deep Serratus Anterior Plane Block

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study includes female patients because mammoplasty surgery is performed in women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 18-75 years
  • ASA physical status I-III
  • Patients scheduled for elective mammoplasty surgery (unilateral or bilateral)
  • Patients who voluntarily agree to participate in the study and provide informed consent

You may not qualify if:

  • ASA physical status IV or higher
  • Patients who refuse to participate in the study
  • Patients who cannot provide informed consent due to language barriers
  • Pregnant patients
  • Active infection at the block application site
  • Previous surgery affecting the anatomical integrity of the block area
  • Known allergy to local anesthetic agents
  • Patients with chronic pain or regular analgesic use
  • Patients with coagulation disorders
  • Patients with neurological or psychiatric disorders affecting pain perception or those using regular antipsychotic or antidepressant medications
  • Body mass index (BMI) \> 40 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam & Sakura City Hospital

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location

Related Publications (4)

  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PMID: 23923989BACKGROUND
  • Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

    PMID: 26824844BACKGROUND
  • von Sperling ML, Hoimyr H, Finnerup K, Jensen TS, Finnerup NB. Persistent pain and sensory changes following cosmetic breast augmentation. Eur J Pain. 2011 Mar;15(3):328-32. doi: 10.1016/j.ejpain.2010.07.004. Epub 2010 Aug 19.

    PMID: 20727797BACKGROUND
  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PMID: 23392233BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 31, 2026

Study Start

November 15, 2024

Primary Completion

March 22, 2026

Study Completion

April 1, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations