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NCT Number: NCT06884852

Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients

The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Ahmed El Abdelaal, Master

CONTACT

[email protected]

00201097900275

Doaa A Mohamed, MD

SUB_INVESTIGATOR

Ghada G Elsayed, MD

SUB_INVESTIGATOR

Mai M Elrawas, MD

PRINCIPAL_INVESTIGATOR

Mohamed A Abdelwadoud, MD

SUB_INVESTIGATOR

About this study

Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.

Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea & vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.

Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients age ≥ 18 years and ≤ 65 Years.
  • Type of surgery; Modified Radical Mastectomy (MRM)
  • Physical status ASA II, III.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion criteria

  • Patient refusal.
  • Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
  • History of psychological disorders.
  • History of chronic pain.
  • Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
  • Advanced chronic renal disease, which is defined as a chronic kidney disease (CKD) in which there is a severe reduction in glomerular filtration rate (GFR < 30 ml/min) and includes stages 4 and 5 of the CKD classification.
  • Decompensated cirrhosis, which is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
  • Severe heart disease which is defined as NYHA class iii (moderate symptoms with less than normal activity, marked limitation of function status) or NYHA class IV (severe symptoms with features of heart failure with minimal activity or at rest and severe limitation of functional status)
  • Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
  • Pregnancy.

Treatment and study plan

Erector spinae plane block (ESPB)

Drug

Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%.

We will inject 15ml at the level of T2 and 15ml at the level of T5.

Other names: Bupivacaine 0.25%

Thoracic epidural block

Drug

Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.

Other names: Bupivacaine 0.25%

Primary outcomes

  1. The average duration of analgesia

    Time frame: 24 hours postoperatively

    The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.

Secondary outcomes

  1. The total amount of morphine

    Time frame: 24 hours postoperatively

    Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups.

  2. Incidence of postmastectomy pain syndrome

    Time frame: 6 months postoperatively

    Incidence of postmastectomy pain syndrome at 1, 3, and 6 months postoperatively will be recorded.

  3. The total amount of fentanyl

    Time frame: Intraoperatively

    Fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of the baseline levels.

  4. Heart rate (HR)

    Time frame: 24 hours Postoperatively

    Heart rate will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively

  5. Mean arterial blood pressure (MAP)

    Time frame: 24 hours Postoperatively

    Mean arterial blood pressure will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively

  6. Degree of pain

    Time frame: 24 hours Postoperatively

    Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be recorded (at rest and during movement) at 0, 4, 8, 12, 16, 20, and 24 hours postoperatively.

  7. Incidence of Postoperative nausea and vomiting (PONV).

    Time frame: 24 hours Postoperatively

    Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild = nausea but no vomiting, moderate= vomiting one attack, severe =vomiting > one attack). 0.1 mg/kg of IV ondansetron will be given to patients with moderate or severe postoperative nausea and vomiting.Nausea and vomiting Scores using a four-point verbal scale; on arrival to post-anesthesia care unit (PACU), scoring at 0, 4, 8,12,16,20 and 24 hours postoperatively.

  8. Complications related to the block

    Time frame: 6 months postoperatively

    Complications related to the block such as local anesthetics, systemic toxicity, and vascular injury will be recorded

  9. Morphine-related complications

    Time frame: 24 hours Postoperatively

    Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. Morphine-related complications such as respiratory depression, urine retention, or pruritis will be recorded.

  10. Patient's satisfaction

    Time frame: 24 hours Postoperatively

    Patient's satisfaction: the patient will be classified in this group as satisfied or not.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed El Abdelaal, Master

CONTACT

[email protected]

00201097900275

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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