Perioperative Analgesic Modalities for Breast Cancer Surgeries

NCT04248608 | Completed

• 1 other identifier: AP1907-50101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects

Conditions

Analgesia

Outcome Measures

Primary Outcomes (3)

• Visual analogue score

  minimum score (0), maximum score (10) maximum score (10)

  24 hours

• Total morphine consumption

  total morphine in mg received in first 24 hours postoprative

  24 hours

• First time to receive morphine

  first time to receive morphine in the postoperative period (first 24 hours)

  24 hours

Secondary Outcomes (2)

• mean arterial blood pressure

  24 hours

• heart rate

  24 hours

Study Arms (3)

erector spinae block

EXPERIMENTAL

Ultrasound guided erector spinae block with will be done after induction of intravenous anesthesia. After identification of trapezius, rhomboid major, and erector spinae muscles. The needle will be inserted in a cephalad-to-caudal direction until the tip contact transverse process and the needle tip is visualized in the plane deep to the erector spinae muscle. The needle tip position is confirmed by visualizing linear spread of test dose between the muscles after injection. A total dose of 25 mL of 0.25% bupivacaine will be injected.

Procedure: erector spinae block

serratus anterior block

EXPERIMENTAL

Ultrasound guided serratus anterior block will be done after induction of intravenous anesthesia. The serratus anterior, latissimus dorsi, and the intercostal muscles will be identified in the fourth and fifth intercostal level, an 18 G Tuohy needle will be advanced in the plane between the serratus anterior muscle and the intercostal muscles. A total dose of bupivacaine 25ml in a concentration of 0.25% will be administered under the serratus muscle after a test dose using an in-plane technique.

Procedure: serratus plane block

intravenous morphine

ACTIVE COMPARATOR

intravenous morphine will be administrated in a dose of 0.1 mg per kg after induction of general anesthesia

Drug: Morphine Sulfate

Interventions

serratus plane block PROCEDURE

ultrasound guided block

Also known as: SAPB

serratus anterior block

erector spinae block PROCEDURE

ultrasound guided block

Also known as: ESPB

erector spinae block

Morphine Sulfate DRUG

intravenous morphine sulfate 0.1 mg/kg

Also known as: opioid

intravenous morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female 18-65 years old patients undergoing modified radical mastectomy

You may not qualify if:

• patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of anesthesia and pain medicine. National Cancer Institute

Cairo, 11796, Egypt

Location

Related Publications (1)

• Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.

  PMID: 33209056 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Morphine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• walaa Y Elsabeeny, MD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and pain management

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 30, 2020
• Study Start: January 28, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)