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

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

Tracking Information

• First Submitted Date: June 28, 2019
• First Posted Date: September 19, 2019
• Last Update Posted Date: October 27, 2020
• Actual Study Start Date: November 12, 2017
• Estimated Primary Completion Date: March 11, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Analgesic Profile In Breast Cancer Surgeries
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Postoperative Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 17, 2019): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2021
• Estimated Primary Completion Date: March 11, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04095455
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
• Study Sponsor: National Cancer Institute, Egypt
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: National Cancer Institute, Egypt
• Verification Date: October 2020