Ultrasound-guided Multilevel Erectorspinae Plane Block Ve... | NCT06884852

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

NCT06884852

Sponsor

National Cancer Institute, Egypt

Status

Recruiting

Last Update Posted

May 21, 2025Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Ultrasound
Multilevel Erector Spinae Plane Block
Thoracic Epidural Analgesia
Post Mastectomy
Pain Syndrome
Breast Cancer Patients

Interventions

Erector spinae plane block (ESPB)
Thoracic epidural block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Mar 13, 2025

First Submission Date that Met QC Criteria

Mar 13, 2025

First Posted Date

Mar 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2025

Last Update Posted Date

May 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Ahmed elsayeh, Assistant Lecturer of Anesthesiology, Surgical Intensive Care Unit and Pain Medicine, National Cancer Institute ,Cairo University, Egypt, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erector spinae plane block (ESPB)	Experimental	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)
Thoracic epidural block	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female patients

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ahmed El Abdelaal, Master	Contact	00201097900275		drahmedsayeh9915@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute	Recruiting	Cairo		11796	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author

URL

Not provided