Clinical trial NCT06436599: Comparison of the Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block and Serratus Posterior Superior Intercostal Plane Block for Breast Surgery: a Randomized Controlled Trial
Official title: Comparison of the Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block and Serratus Posterior Superior Intercostal Plane Block for Breast Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind
Primary purpose: SUPPORTIVE_CARE

Brief summary: The application 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. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of tramadol(mg) consumption
timeFrame: within 24 hours postoperative
Secondary outcomes:
measure: Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score
timeFrame: within 24 hours postoperative
measure: perioperative remifentanil consumption
timeFrame: perioperative
measure: rescue anesthesia
timeFrame: within 24 hours postoperative
measure: postoperative nausea-vomiting (PONV)
timeFrame: within 24 hours postoperative
measure: surgeon and patient satisfaction (5-point Likert scale)
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Professor Doctor Süleyman Yalçın City Hospital
Study officials:
References: