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Perioperative Analgesic Modalities for Breast Cancer Surgeries

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT04248608
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
5.1
Actual Duration (Months)
14.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: serratus plane block
  • Procedure: erector spinae block
  • Drug: Morphine Sulfate
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Perioperative Analgesic Modalities for Breast Cancer Surgeries
Actual Study Start Date :
Jan 28, 2020
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: erector spinae block
ultrasound guided block
Other Names:
  • ESPB

    		•
    Experimental: 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.

    Procedure: serratus plane block
    ultrasound guided block
    Other Names:
  • SAPB

    		•
    Active Comparator: intravenous morphine

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual analogue score [24 hours]

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

    2. Total morphine consumption [24 hours]

      total morphine in mg received in first 24 hours postoprative

    3. First time to receive morphine [24 hours]

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

    Secondary Outcome Measures

    1. mean arterial blood pressure [24 hours]

      hemodynamic parameters

    2. heart rate [24 hours]

      hemodynamic parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of anesthesia and pain medicine. National Cancer Institute Cairo Egypt 11796

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

    • Principal Investigator: walaa Y Elsabeeny, MD, Lecturer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Youssef Elsabeeny, lecturer of anesthesia and pain management, National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT04248608
    Other Study ID Numbers:
    • AP1907-50101
    First Posted:
    Jan 30, 2020
    Last Update Posted:
    Jul 21, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Morphine

    Study Results

    No Results Posted as of Jul 21, 2020