Perioperative Analgesic Modalities for Breast Cancer Surgeries

NCT ID: NCT04248608

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2020-07-01

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

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

erector spinae block

Intervention Type: PROCEDURE

ultrasound guided 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.

Group Type: EXPERIMENTAL

serratus plane block

Intervention Type: PROCEDURE

ultrasound guided block

intravenous morphine

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

Group Type: ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

intravenous morphine sulfate 0.1 mg/kg

Interventions

serratus plane block

ultrasound guided block

Intervention Type: PROCEDURE

erector spinae block

ultrasound guided block

Intervention Type: PROCEDURE

Morphine Sulfate

intravenous morphine sulfate 0.1 mg/kg

Intervention Type: DRUG

Other Intervention Names

SAPB; ESPB; opioid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Walaa Youssef Elsabeeny

lecturer of anesthesia and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

Department of anesthesia and pain medicine. National Cancer Institute

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33209056 (View on PubMed)

Other Identifiers

AP1907-50101

Identifier Type: -

Identifier Source: org_study_id