Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID07041762

Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery

Led by Cairo University · Updated on 2025-06-27

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two nerve block techniques, Rhomboid Intercostal Block with Sub-Serratus Plane Block (RIB + SSP) and Erector Spinae Plane Block (ESB), for pain relief after breast cancer surgery. The study focuses on patients undergoing Modified Radical Mastectomy and aims to find which method better controls postoperative pain, reduces opioid use, and improves recovery. This randomized controlled trial involves female patients aged 18 to 65 with specific health status and body mass index requirements. Participants will be randomly assigned to receive either RIB + SSP or ESB before surgery. The RIB + SSP group receives two ultrasound-guided injections of 0.25% bupivacaine (20 mL each) at specific muscle and rib locations 30-45 minutes before general anesthesia. The ESB group receives a single ultrasound-guided injection of 30 mL of 0.25% bupivacaine near the spine at the T4-T5 level within the same time frame. Both procedures are performed under ultrasound guidance prior to surgery. During the study, participants will be monitored for postoperative pain using the Visual Analog Scale and total opioid consumption during the first 24 hours after surgery. Additional assessments include hemodynamic measures during and after surgery, time to first analgesic request, total opioid use during surgery, recovery duration, patient satisfaction, and side effects such as nausea and vomiting. The study is conducted from June 2025 to June 2026 at the National Cancer Institute, Cairo University, with ethical approval and informed consent.

CONDITIONS

Brief Title

Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female breast cancer patients undergoing Modified Radical Mastectomy (MRM)
  • ASA physical status II or III
  • Age between 18 and 65 years
  • Body Mass Index (BMI) greater than 20 kg/m² and less than 35 kg/m²
Not Eligible

You will not qualify if you...

  • Patient refusal
  • ASA physical status IV
  • Age less than 18 years or greater than 65 years
  • Body Mass Index (BMI) less than 20 kg/m² or greater than 35 kg/m²
  • Known allergy or contraindication to local anesthetics or opioids
  • History of psychological disorders or chronic pain
  • Contraindications to regional anesthesia such as coagulopathy, local infection, or peripheral neuropathy
  • Severe respiratory, cardiac, hepatic, or renal disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day (day of surgery)

Participants receive either the Rhomboid Intercostal Block with Sub-Serratus Plane Block or the Erector Spinae Plane Block under ultrasound guidance 30-45 minutes before general anesthesia for Modified Radical Mastectomy surgery.

1 procedure visit (in-person)

Follow-up

Duration - 24 hours post surgery

Participants are monitored for pain scores and opioid consumption during the first 24 hours after surgery to assess analgesic efficacy and safety.

Approximately 1 follow-up visit within 24 hours

Trial Site Locations

Total: 1 location

1

National Cancer Institute - Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

S

Sayed Mahmoud M Abed, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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