- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432256
Parasternal Block Added to Serratus Anterior Plane Block in Breast Reduction Surgery
The Effect of Adding a Parasternal Intercostal Plane Block to a Serratus Anterior Plane Block on Postoperative Opioid Consumption in Breast Reduction Surgery
This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery.
All patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption.
The study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maltepe
-
Zonguldak, Maltepe, Turkey (Türkiye)
- Zonguldak Bulent Ecevit University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18-65 years
- Scheduled for elective breast reduction surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study and provide written informed consent
Exclusion Criteria:
Patient refusal
- Known allergy to local anesthetics
- Coagulopathy or ongoing anticoagulant therapy
- Infection at the block site
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
patients receive standard general anesthesia
|
|
|
Active Comparator: Serratus Anterior Plane Block
patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery
|
injection local anesthetic between 5th rib and serratus anterior muscle
|
|
Active Comparator: Serratus Anterior Plane Block + Parasternal Intercostal Plane Block
patients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery
|
both injection local anesthetic between 5th rib and serratus anterior muscle at midaxillary line and between 4th costal cartilage and pectoralis major muscle at next to the sternum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total postoperative opioid consumption in the first 24 hours
Time Frame: First 24 hours after surgery
|
Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the study groups.
|
First 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery by using QoR-15 questionnaire
Time Frame: postoperative 24th hour
|
postoperative 24th hour
|
|
|
Pain Scores
Time Frame: postoperative 0, 1, 2, 6, 12, 24 th hour
|
using NRS Scale
|
postoperative 0, 1, 2, 6, 12, 24 th hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Agnosia
- Enzymes and Coenzymes
- Coenzymes
- Sphingolipid Activator Proteins
- Saposins
Other Study ID Numbers
- 2024/08-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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