Postoperative Analgesic Effectiveness of Fascial Plane Blocks in Breast Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 80 years

American society of anesthesiologists physical status I to III

Undergoing surgery under general anesthesia

Provision of written informed consent

Disqualifiers

History of allergy to local anesthetic medications

Coagulation disorder

Body mass index greater than 40 kg/m2

Infection at the block application site

Trial population

Participants aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia at the single study center, provide written informed consent, and meet all eligibility criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rhomboid intercostal plane block

    Procedure/Surgery

    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/Surgery

    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.

  • Control Group

    Procedure/Surgery

    Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Rhomboid Intercostal Plane Block Group2 interventions
Group B: Serratus Posterior Superior Intercostal Plane Block Group2 interventions
Group C: Control Group1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Tramadol Consumption During the First 24 Hours After Surgery

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

Time frame
During the first 24 postoperative hours

Secondary outcomes

1

Numeric Rating Scale Pain Score at Rest

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.

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

Numeric Rating Scale Pain Score During Movement

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.

Time frame
At postoperative hours 0, 2, 4, 6, 12, and 24
3

Dermatomal Extent of Sensory Block Assessed by Pinprick

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

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

Incidence of Postoperative Nausea and Vomiting

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

Time frame
During the first 24 postoperative hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.