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NCT Number: NCT07830446

Postoperative Analgesic Effectiveness of Fascial Plane Blocks in Breast Surgery

This prospective, single-center observational study will compare postoperative pain control in adults undergoing elective breast surgery. Ninety participants will be evaluated in three groups based on routine clinical care: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The anesthesia method and fascial plane block will be selected by the treating anesthesiologist, and the research team will not assign participants to a group. The main outcome is the total amount of tramadol used through patient-controlled analgesia during the first 24 hours after surgery. Pain scores at rest and during movement, sensory block levels, postoperative nausea and vomiting, and block-related complications will also be recorded.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location status: Recruiting

Location contact

Korgün Ökmen

CONTACT

[email protected]

+90 505 708 10 21

About this study

Patients aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia and meet the eligibility criteria will be enrolled after providing written informed consent. Group classification will reflect the regional analgesia approach selected as part of routine care by the treating anesthesiologist. The investigators will not participate in the selection of the anesthesia method, the fascial plane block, or the study group.

The study will include 90 participants in three observational cohorts: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The primary outcome is cumulative tramadol consumption recorded by patient-controlled analgesia during the first 24 postoperative hours. Secondary assessments include Numeric Rating Scale pain scores at rest and during movement at postoperative hours 0, 2, 4, 6, 12, and 24; sensory block level assessed by pinprick testing in the block groups; postoperative nausea and vomiting; and block-related complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 80 years
  • ASA physical status I to III
  • Undergoing surgery under general anesthesia
  • Provision of written informed consent
  • Scheduled for elective breast surgery

Exclusion criteria

  • History of allergy to local anesthetic medications
  • Coagulation disorder
  • Body mass index greater than 40 kg/m2
  • Infection at the block application site
  • Chronic pain syndrome
  • Pregnancy
  • Inability to communicate
  • Requirement for emergency surgery

Treatment and study plan

Rhomboid intercostal plane block

Procedure

A fascial plane block in which local anesthetic is injected into the plane between the rhomboid major and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.

Serratus Posterior Superior Intercostal Plane Block

Procedure

A fascial plane block in which local anesthetic is injected into the plane between the serratus posterior superior and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.

Primary outcomes

  1. Cumulative Tramadol Consumption During the First 24 Hours After Surgery

    Time frame: During the first 24 postoperative hours

    The total amount of tramadol consumed through the patient-controlled analgesia device will be recorded in milligrams at postoperative hour 24.

Secondary outcomes

  1. Numeric Rating Scale Pain Score at Rest

    Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24

    Pain intensity at rest will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.

  2. Numeric Rating Scale Pain Score During Movement

    Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24

    Pain intensity during movement, including coughing or deep breathing, will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.

  3. Dermatomal Extent of Sensory Block Assessed by Pinprick

    Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24

    Among participants in the block groups, sensory block will be assessed by pinprick, and the upper and lower dermatomal boundaries will be recorded.

  4. Incidence of Postoperative Nausea and Vomiting

    Time frame: During the first 24 postoperative hours

    The occurrence of postoperative nausea and vomiting will be recorded for each participant.

  5. Incidence of Block-Related Complications

    Time frame: During the first 24 postoperative hours

    Block-related complications will be recorded among participants in the block groups.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast Surgery: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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