- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436599
SPSIPB Versus Deep SAPB for Analgesia After Breast Surgery
Comparison of Serratus Posterior Superior Intercostal Plane Block Versus Deep Serratus Anterior Plane Block for Postoperative Analgesia After Breast Surgery: a Prospective Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.
Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.
In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.
Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.
The aim of our study was to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Professor Doctor Süleyman Yalçın City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- unilateral mastectomy(modified radial mastectomy)
- ASA I-III risk group
Exclusion Criteria:
- Coagulopathy
- Wound and infection in the block area
- Local anaesthetic allergy
- Mental retardation
- Non-cooperative
- Pregnant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Patients with serratus posterior superior intercostal plan block
Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative analgesia
|
evaluation of the efficacy of two different plan blocks for postoperative analgesia
Other Names:
|
|
Active Comparator: Patients with serratus anterior plan block
Serratus anterior plane block was applied to a certain group of patients for postoperative analgesia
|
evaluation of the efficacy of two different plan blocks for postoperative analgesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)
Time Frame: within 24 hours postoperative
|
Evaluation of which of the two plan blocks is more effective in postoperative analgesia. Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain. |
within 24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rescue anesthesia
Time Frame: within 24 hours postoperative
|
In the postoperative 24-hour period, tenoxicam will be administered and recorded as rescue analgesia to patients who feel pain despite patient-controlled nalgesia (tramadol).
|
within 24 hours postoperative
|
|
postoperative nausea-vomiting (PONV)
Time Frame: within 24 hours postoperative
|
The number of times of nausea and vomiting in the postoperative period will be recorded and compared in both patient groups.
A lower numerical value of postoperative nausea-vomiting indicates better patient comfort in the postoperative period.
|
within 24 hours postoperative
|
|
perioperative remifentanil consumption
Time Frame: perioperative
|
The amounts (mcg) of remifantanil consumed during the surgical procedure will be compared
|
perioperative
|
|
Comparison of tramadol(mg) consumption
Time Frame: within 24 hours postoperative
|
Using a patient-controlled analgesia device, tramadol consumption and total tramadol consumption will be compared between 0-1st hour, 1st-4th hour, 4th-8th hour, 8th-12th hour, 12th-24th hour postoperatively..
|
within 24 hours postoperative
|
|
patient satisfaction (5-point Likert scale)
Time Frame: 24 hours after surgery
|
At postoperative discharge, 5-point Likert satisfaction questionnaire will be administered to the patient.
A high numerical value on a five-point Likert satisfaction scale indicates that the patient are satisfied with the procedure performed.
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/0870
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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