Perioperative Analgesic Modalities for Breast Cancer Surgeries

Analgesia Clinical Trial

Official title:

Perioperative Analgesic Modalities for Breast Cancer Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248608
• Other study ID #: AP1907-50101
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• serratus plane block
ultrasound guided block
• erector spinae block
ultrasound guided block

Drug:
• Morphine Sulfate
intravenous morphine sulfate 0.1 mg/kg

Locations

Country	Name	City	State
Egypt	Department of anesthesia and pain medicine. National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score	minimum score (0), maximum score (10) maximum score (10)	24 hours
Primary	Total morphine consumption	total morphine in mg received in first 24 hours postoprative	24 hours
Primary	First time to receive morphine	first time to receive morphine in the postoperative period (first 24 hours)	24 hours
Secondary	mean arterial blood pressure	hemodynamic parameters	24 hours
Secondary	heart rate	hemodynamic parameters	24 hours