Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery

NCT07229092 | Active Not Recruiting

• 1 other identifier: ADU-SAPB-RIPB-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized clinical study aims to compare the analgesic efficacy of serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) for postoperative analgesia in patients undergoing elective bilateral breast reduction surgery under general anesthesia. All patients will receive standardized general anesthesia. Before induction of anesthesia, while patients are awake, Group SPB will receive an ultrasound-guided serratus anterior plane block and Group RIPB will receive an ultrasound-guided rhomboid intercostal plane block. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (PCA) with opioids. Primary outcomes include postoperative pain scores and opioid consumption at 1, 6, 12, and 24 hours. Secondary outcomes include time to first analgesic demand, patient satisfaction, and block-related complications.

Conditions

Postoperative Pain; Postoperative Pain Breast Reduction; Pain, Postoperative; Postoperative Analgesia in Breast Reduction Surgery

Outcome Measures

Primary Outcomes (1)

• Total Tramadol Consumption Within the First 24 Hours After Surgery

  Total opioid consumption will be recorded using intravenous patient-controlled analgesia (PCA) during the first 24 hours after surgery. The cumulative tramadol dose (mg) administered via PCA will be calculated based on the number of patient-controlled bolus doses.

  24 hours after surgery

Secondary Outcomes (1)

• Postoperative Pain Scores (NRS) at Rest and During Movement at 1, 6, 12, and 24 Hours

  1, 6, 12, and 24 hours after surgery

Study Arms (3)

Serratus Plane Block

EXPERIMENTAL

"Patients in this group will receive an ultrasound-guided serratus anterior plane block (SAPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered to the right side and 15 mL to the left side. Each side will receive a single injection point along the midaxillary line to provide adequate spread within the serratus plane.

Procedure: Serratus Anterior Plane Block (SAPB)

Rhomboid Intercostal Plane Block

ACTIVE COMPARATOR

"Patients in this group will receive an ultrasound-guided rhomboid intercostal plane block (RIPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered on the right and 15 mL on the left. Each side will receive a single injection point beneath the medial border of the scapula at the level of the intercostal plane to ensure adequate spread between the rhomboid major muscle and intercostal muscles."

Procedure: Rhomboid Intercostal Plane Block (RIPB)

Control Group (No Block)

OTHER

Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol

Other: No Regional Block (Control)

Interventions

Rhomboid Intercostal Plane Block (RIPB) PROCEDURE

Ultrasound-guided rhomboid intercostal plane block (RIPB) performed preoperatively while patients are awake, using a total of 30 mL local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine). The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side between the rhomboid major muscle and the intercostal muscles at the medial border of the scapula around the 5th intercostal level.

Rhomboid Intercostal Plane Block

No Regional Block (Control) OTHER

Participants in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.

Control Group (No Block)

Serratus Anterior Plane Block (SAPB) PROCEDURE

"Ultrasound-guided serratus anterior plane block performed preoperatively while patients are awake. A total of 30 mL of local anesthetic solution (5 mL saline, 5 mL of 2% lidocaine, 20 mL of 0.25% bupivacaine) will be used. The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side at the midaxillary line

Serratus Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only biologically female patients undergoing elective breast reduction surgery will be eligible to participate in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective bilateral breast reduction surgery under general anesthesia
• Willing and able to provide written informed consent

You may not qualify if:

• Allergy or contraindication to local anesthetics (bupivacaine)
• Coagulopathy or anticoagulant medication use
• Infection at or near the injection site
• History of chronic opioid use or psychiatric/neurological disorders affecting pain perception
• Body mass index (BMI) \> 35 kg/m²
• Refusal to participate in the study

Sponsors & Collaborators

• Konul Karaja: lead

Study Sites (1)

Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation

Aydin, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Konul karaja, MD

  Aydın Adnan Menderes University Hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patients and the outcome assessor who recorded postoperative pain scores were blinded to the type of block performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology Research Fellow / MD

Model Details: The study includes three parallel groups. Patients undergoing breast reduction surgery are randomly assigned to receive ultrasound-guided serratus anterior plane block (SAPB), ultrasound-guided rhomboid intercostal plane block (RIPB), or no regional block for postoperative analgesia.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: February 2, 2025
• Primary Completion: February 9, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

TU (1)