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

NCT ID: NCT07229092

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-02

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Postoperative pain management in breast reduction surgery is challenging due to wide tissue dissection and thoracic wall involvement. Serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) are regional anesthesia techniques that provide analgesia by blocking the lateral cutaneous branches of the intercostal nerves.

This randomized controlled trial will compare the analgesic efficacy of SPB and RIPB in female patients aged 18-65 undergoing elective bilateral breast reduction surgery under general anesthesia.

Before induction of general anesthesia, while patients are awake, ultrasound-guided SPB or RIPB will be performed according to group allocation. After block performance, general anesthesia will be induced using a standardized protocol. Postoperative pain management will be provided with intravenous patient-controlled analgesia (PCA) with opioids.

Primary outcomes include postoperative pain scores (NRS) and opioid consumption. Secondary outcomes include duration of analgesia, time to first analgesic request, patient satisfaction, and block-related complications. The hypothesis is that both blocks will reduce postoperative pain and opioid consumption, but the duration and quality of analgesia may differ between SPB and RIPB.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study includes two parallel groups. Patients undergoing breast reduction surgery will be randomly assigned to receive either ultrasound-guided serratus plane block (SPB) or rhomboid intercostal plane block (RIPB) for postoperative analgesia.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients and the outcome assessor who recorded postoperative pain scores were blinded to the type of block performed

Study Groups

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Serratus Plane Block

"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.

Group Type EXPERIMENTAL

Serratus Plane Block

Intervention Type 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

Rhomboid Intercostal Plane Block

"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."

Group Type ACTIVE_COMPARATOR

Rhomboid Intercostal Plane Block (RIPB)

Intervention Type 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.

Control Group (No Block)

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

Group Type OTHER

No Regional Block (Control)

Intervention Type 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.

Interventions

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Serratus Plane Block

"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

Intervention Type PROCEDURE

Rhomboid Intercostal Plane Block (RIPB)

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.

Intervention Type PROCEDURE

No Regional Block (Control)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konul Karaja

OTHER

Sponsor Role lead

Responsible Party

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Konul Karaja

Anesthesiology Research Fellow / MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Konul karaja, MD

Role: PRINCIPAL_INVESTIGATOR

Aydın Adnan Menderes University Hospita

Locations

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Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation

Aydin, Aydın, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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konul karaja, MD

Role: CONTACT

+905550948199

kamil Varlık Erel, prof

Role: CONTACT

+905324439202

Other Identifiers

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ADU-SAPB-RIPB-2025

Identifier Type: -

Identifier Source: org_study_id

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