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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Pain Syndrome; Thoracic Epidural Analgesia; Breast Cancer Patients; Post Mastectomy; Multilevel Erector Spinae Plane Block
• Intervention / Treatment: Drug: Erector spinae plane block (ESPB); Drug: Thoracic epidural block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed El Abdelaal, Master; Phone Number: 00201097900275; Email: drahmedsayeh9915@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute
    • Contact: Ahmed El Abdelaal, Master; Phone Number: 00201097900275; Email: drahmedsayeh9915@gmail.com
    • Sub-Investigator: Ghada G Elsayed, MD
    • Sub-Investigator: Mohamed A Abdelwadoud, MD
    • Principal Investigator: Mai M Elrawas, MD
    • Sub-Investigator: Doaa A Mohamed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector spinae plane block (ESPB); Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We injected 15ml at the level of T2 and 15ml at the level of T5.	Drug: Erector spinae plane block (ESPB); 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%
Experimental: Thoracic epidural block; 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.	Drug: Thoracic epidural block; 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average duration of analgesia	The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of morphine	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.	24 hours postoperatively
Incidence of postmastectomy pain syndrome	Incidence of postmastectomy pain syndrome at 1, 3, and 6 months postoperatively will be recorded.	6 months postoperatively
The total amount of fentanyl	Fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of the baseline levels.	Intraoperatively
Heart rate (HR)	Heart rate will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively	24 hours Postoperatively
Mean arterial blood pressure (MAP)	Mean arterial blood pressure will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively	24 hours Postoperatively
Degree of pain	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.	24 hours Postoperatively
Incidence of Postoperative nausea and vomiting (PONV).	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.	24 hours Postoperatively
Complications related to the block	Complications related to the block such as local anesthetics, systemic toxicity, and vascular injury will be recorded	6 months postoperatively
Morphine-related complications	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.	24 hours Postoperatively
Patient's satisfaction	Patient's satisfaction: the patient will be classified in this group as satisfied or not.	24 hours Postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease; Skin Diseases; Breast Diseases; Somatoform Disorders; Syndrome; Breast Neoplasms; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: AP2405-201-046-193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No