The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Analgesic Profile In Breast Cancer Surgeries

Ketamine

Brief Summary

Background: Postoperative pain is one of the greatest patient concerns following surgery. However, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation. Hypothesis: The investigators assume that both ultrasound guided Modified Pecs Block and combination of Ketamine and Magnesium sulphate infusion can achieve better analgesia in major breast cancer surgery in the form of reducing total amount of intraoperative fentanyl requirement and reducing postoperative morphine requirement and improvement of postoperative VAS scores both at rest and during shoulder movement so we plan this study to evaluate this assumption

Intervention / Treatment

  • pectoral nerves block group (PROCEDURE)
    ultrasound guided block of nerve supply of surgical site
  • Ketamine plus magnesium group (DRUG)
    Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump (Atom Syringe Pump S-1235).
  • Control group (DRUG)
    Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 75 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 12, 2017 ACTUAL
    Primary Completion: Mar 11, 2021 ESTIMATED
    Completion Date: Apr 15, 2021 ESTIMATED
    Study First Posted: Sep 19, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 24, 2020

    Sponsors / Collaborators

    Lead Sponsor: National Cancer Institute, Egypt
    Responsible Party: N/A

    Location

    Giza, Egypt

    Surgery on the chest wall is relatively common and can be associated with significant postoperative discomfort and pain; and one of the most common surgical sites on the chest wall is the breast, with the main indication for breast surgery being breast cancer. Breast cancer has continued to be the most common cancer in females, accounting for approximately 31% of all newly detected cancer cases in the female population, worldwide. (1, 2) Thousands of patients undergo surgery in the mammary and axillary regions every year, and these procedures tend to cause significant acute pain and may develop in to cases of chronic pain in 25-60% of cases. (3) Pain can be controlled using systemic opioids which have a respiratory depressant effect and causing nausea and vomiting.

    Also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.

    Participant Groups

    • modified pectoral nerves block was performed on the side of surgery

    • Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump

    • Normal saline infusion with similar rate and volume to KM infusion was used as a placebo

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * female patients with American society of Anesthesia classification(ASA) II physical status undergoing major breast cancer surgery with axillary evacuation under general anesthesia.
    * Patients' age from18 to 65 Years.
    * Body mass index (BMI) are from 20 to 40 kg/m2.

    Exclusion Criteria:

    * Pregnant patients
    * Patients having sensitivity or contraindication to test drugs or regional anesthesia.
    * severe respiratory or cardiac disorders.
    * history of psychological disorder.
    * chronic pain .
    * significant liver or renal insufficiency. .

    Primary Outcomes

    • calculating the total dose of morphine consumed in postoperative analgesia

    Secondary Outcomes

    • Total amount of fentanyl used by the anesthetic provider in the operating room

    • assessement of Pain intensity in the PACU using the visual analogue scale (VAS) scores, both at rest and during shoulder movement, a scale from 0 to 10. scores towards 0 is reveal good analgesia.

    • Sedation score assessement in Post Anesthesia Care Unit according to ramasy sedation score.(125) a scale from 1 to 6 with the preferred scores 2 or 3.

    • assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred.

    More Details

    NCT Number: NCT04095455
    Other IDs: N10-2017
    Study URL: https://clinicaltrials.gov/study/NCT04095455
    Last updated: Sep 29, 2023