- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229092
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery (SAPB-RIPB)
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aydın
-
Aydin, Aydın, Turkey (Türkiye), 09010
- Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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
|
Participants in this group will not receive any regional block.
Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.
|
|
Experimental: 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.
|
"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
|
|
Active Comparator: 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."
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tramadol Consumption Within the First 24 Hours After Surgery
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores (NRS) at Rest and During Movement at 1, 6, 12, and 24 Hours
Time Frame: 1, 6, 12, and 24 hours after surgery
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS), a 0-10 point scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores will be recorded at rest and during movement at 1, 6, 12, and 24 hours after surgery
|
1, 6, 12, and 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Konul karaja, MD, Aydın Adnan Menderes University Hospita
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADU-SAPB-RIPB-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on No Regional Block (Control)
-
Kartal Kosuyolu Yuksek Ihtisas Education and Research...RecruitingPostoperative PainTurkey
-
Shaukat Khanum Memorial Cancer Hospital & Research...Completed
-
Istinye UniversityRecruitingLiver Transplantation | Postoperative Pain | Living DonorTurkey (Türkiye)
-
Hospital DonostiaCompletedErector Spinae Plane Block | Regional Anaesthesia | Video Assisted Thoracic Surgery (VATS) | ERAS ProgrammesSpain
-
Seoul National University HospitalRecruitingBreast Cancer | RadiotherapyKorea, Republic of
-
Technische Universität DresdenMathys Ltd BettlachCompleted
-
King Edward Medical UniversityCompleted
-
University of PennsylvaniaPatient-Centered Outcomes Research InstituteCompletedHip FracturesUnited States, Canada
-
Auckland City HospitalTerminatedDelirium | Hip FractureNew Zealand
-
Jing Cai, MDZhongshan People's Hospital, Guangdong, China; Zhongshan Hospital Of Traditional...RecruitingSepsis | Acute Gastrointestinal Injury | Organ Dysfunction SyndromeChina