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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: pectoral nerves block group
* Drug: Ketamine plus magnesium group
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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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. .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pectoral nerves block group<br>modified pectoral nerves block was performed on the side of surgery | Procedure: pectoral nerves block group<br>* ultrasound guided block of nerve supply of surgical site<br>|
| Active Comparator: Ktamine plus Magnesium group<br>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 | Drug: Ketamine plus magnesium group<br>* 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).<br>|
| Active Comparator: Control Group<br>Normal saline infusion with similar rate and volume to KM infusion was used as a placebo | Drug: Control group<br>* Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine requirements | calculating the total dose of morphine consumed in postoperative analgesia | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fentanyl consumption | Total amount of fentanyl used by the anesthetic provider in the operating room | intraoperative period | 
| Visual analogue scale score | 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. | immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively. | 
| Sedation score | 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. | A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively. | 
| Nausea and vomiting | assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred. | during the first post-operative 24 hours |