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Clinical Trials/NCT04248608
NCT04248608
Completed
Not Applicable

Perioperative Analgesic Modalities for Breast Cancer Surgeries

National Cancer Institute, Egypt1 site in 1 country75 target enrollmentJanuary 28, 2020

Overview

Phase
Not Applicable
Intervention
erector spinae block
Conditions
Analgesia
Sponsor
National Cancer Institute, Egypt
Enrollment
75
Locations
1
Primary Endpoint
Visual analogue score
Status
Completed
Last Updated
5 years ago

Overview

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

Detailed Description

One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects

Registry
clinicaltrials.gov
Start Date
January 28, 2020
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Walaa Youssef Elsabeeny

lecturer of anesthesia and pain management

National Cancer Institute, Egypt

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

erector spinae block

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.

Intervention: erector spinae block

serratus anterior block

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.

Intervention: serratus plane block

intravenous morphine

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

Intervention: Morphine Sulfate

Outcomes

Primary Outcomes

Visual analogue score

Time Frame: 24 hours

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

Total morphine consumption

Time Frame: 24 hours

total morphine in mg received in first 24 hours postoprative

First time to receive morphine

Time Frame: 24 hours

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

Secondary Outcomes

  • mean arterial blood pressure(24 hours)
  • heart rate(24 hours)

Study Sites (1)

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