Perioperative Analgesic Modalities for Breast Cancer Surgeries

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: erector spinae block; Procedure: serratus plane block; Drug: Morphine Sulfate

• Registration Number: NCT04248608
• Lead Sponsor: National Cancer Institute, Egypt

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

Study Timeline

• Study First Submitted: 2020-01-22
• Study Start: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae block	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.
serratus anterior block	serratus plane 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.
intravenous morphine	Morphine Sulfate	intravenous morphine will be administrated in a dose of 0.1 mg per kg after induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
Visual analogue score	24 hours	minimum score (0), maximum score (10) maximum score (10)
Total morphine consumption	24 hours	total morphine in mg received in first 24 hours postoprative
First time to receive morphine	24 hours	first time to receive morphine in the postoperative period (first 24 hours)

Secondary Outcome Measures

Name	Time	Method
mean arterial blood pressure	24 hours	hemodynamic parameters
heart rate	24 hours	hemodynamic parameters

Trial Locations

Locations (1)

Department of anesthesia and pain medicine. National Cancer Institute; 🇪🇬 Cairo, Egypt