Mastectomy Clinical Trials

Clinical trials related to Mastectomy Procedure

Comparison of Analgesic Efficacy and Opioid Consumption of Erector Spinae Plane Block Versus Serratus Anterior Block With Additional Pecto-Intercostal II Block in Breast-Conserving Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective randomized study will compare the effects of Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block combined with Pectoral Nerve Block Type II (SAPB + PECS II) on intraoperative analgesia and postoperative opioid consumption in patients undergoing breast cancer surgery. Seventy patients (ASA I-III, aged 18-75 years) will be randomized into two groups using the sealed envelope method. Ultrasound-guided blocks will be performed preoperatively by the same anesthesiologist, with Group 1 receiving ESPB and Group 2 receiving a combined SAPB + PECS II technique performed through a single skin puncture (single needle entry site) with sequential injections into the two target fascial planes. All patients will undergo surgery under general anesthesia and receive postoperative analgesia via morphine patient-controlled analgesia. Pain scores and total opioid consumption will be statistically analyzed, with p \< 0.05 considered significant.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age between 18 and 75 years

• ASA physical status I-III

• No history of bleeding or coagulation disorders

• Absence of neuropathy

• Preoperative breast region NRS score \< 4

Locations
Other Locations
Turkey
Kasyeri City Hospital
RECRUITING
Kayseri
Contact Information
Primary
Erdoğan Rahmi Çinçin, Resident Doctor
erdo.cincin@gmail.com
+90538 862 31 08
Backup
Çiğdem Ünal Kantekin, Associate Professor of Medicin
drcgdm@gmail.com
+905054433056
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Erector Spinae Plane Block
Standard preoperative monitoring, including ECG, SpO₂, and non-invasive blood pressure (NIBP), will be applied under operating room conditions. Patients will be positioned in the lateral decubitus position with the operative side facing upward. A PHILIPS ClearVue 550 ultrasound device with a high-resolution linear probe (12-5 MHz) will be used. The probe and cable will be covered with a sterile sheath, sterile ultrasound gel will be applied, and skin antisepsis will be achieved using povidone-iodine.~The transverse process beneath the erector spinae muscle will be targeted. A 22G atraumatic, nerve stimulator-equipped block needle (B. Braun Stimuplex® Ultra 360, 0.7 × 80 mm) will be advanced in-plane from lateral to medial. After confirmation of correct placement by saline hydrodissection, 35 mL of 0.25% bupivacaine will be injected slowly, and longitudinal spread will be observed. Block success will be assessed using the pinprick test.
Active_comparator: SAPB + PECS II Technique
Standard monitoring will be applied. Patients will be placed in the supine position with the ipsilateral arm abducted. Using the same ultrasound equipment, the PECS II block will be performed first. The needle will be advanced in-plane between the pectoralis minor and serratus anterior muscles, and 15 mL of 0.25% bupivacaine will be injected after hydrodissection. Both blocks will be performed through a single skin puncture (single needle entry site); without withdrawing the needle from the skin, it will be redirected under ultrasound guidance to access the second target fascial plane. Subsequently, the SAPB will be performed by advancing the probe to the 5th or 6th rib level. The needle will be placed beneath the serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be injected following confirmation of the correct fascial plane. Block efficacy will again be assessed using the pinprick test.
Related Therapeutic Areas
Sponsors
Leads: Kayseri City Hospital

This content was sourced from clinicaltrials.gov