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

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ClinicalTrials.gov Identifier: NCT04095455
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE November 12, 2017
Estimated Primary Completion Date March 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
total morphine requirements [ Time Frame: 24 hours postoperatively ]
calculating the total dose of morphine consumed in postoperative analgesia
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • fentanyl consumption [ Time Frame: intraoperative period ]
    Total amount of fentanyl used by the anesthetic provider in the operating room
  • Visual analogue scale score [ Time Frame: immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively. ]
    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 [ Time Frame: A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively. ]
    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.
  • Nausea and vomiting [ Time Frame: during the first post-operative 24 hours ]
    assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Analgesic Profile In Breast Cancer Surgeries
Official Title  ICMJE The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Perioperative Analgesic Profile In Major Breast Cancer Surgeries: Randomized Controlled Study
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

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Procedure: pectoral nerves block group
    ultrasound guided block of nerve supply of surgical site
  • Drug: Ketamine plus magnesium group
    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).
  • Drug: Control group
    Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
Study Arms  ICMJE
  • Active Comparator: pectoral nerves block group
    modified pectoral nerves block was performed on the side of surgery
    Intervention: Procedure: pectoral nerves block group
  • Active Comparator: Ktamine plus Magnesium group
    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
    Intervention: Drug: Ketamine plus magnesium group
  • Active Comparator: Control Group
    Normal saline infusion with similar rate and volume to KM infusion was used as a placebo
    Intervention: Drug: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date March 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. .
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04095455
Other Study ID Numbers  ICMJE N10-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
Study Sponsor  ICMJE National Cancer Institute, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Cancer Institute, Egypt
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP