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RECRUITING Not applicable ClinicalTrials.gov

Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy

Sponsor: Cairo University • ClinicalTrials.gov ID: NCT07446868

Registry updated: 2026-09-01
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Description

Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine. Regional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief. The purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting. This study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.

Interventions

  • Serratus Posterior Superior Intercostal Plane Block (Procedure)
    Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery.
  • Erector Spinae Plane Block (Procedure)
    Ultrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery.

Eligibility criteria

Inclusion Criteria: Female patients diagnosed with breast cancer Scheduled for modified radical mastectomy (MRM) American Society of Anesthesiologists (ASA) physical status II or III Age 18-65 years Body mass index (BMI) \> 20 kg/m² and \< 35 kg/m² Ability to understand the study protocol and provide written informed consent Exclusion Criteria: Patient refusal to participate ASA physical status IV or higher BMI ≤ 20 kg/m² or ≥ 35 kg/m² Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications History of chronic pain or regular opioid use Significant psychiatric disorders affecting pain assessment Contraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy) Severe respiratory, cardiac, hepatic, or renal disease

Conditions

Breast Cancer Postoperative Pain Acute Post-surgical Pain

Locations

  • National Cancer Institute - Cairo University — Cairo, Cairo Governorate, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record