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

National Cancer Institute, Egypt

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain

Treatments: Procedure: pectoral nerves block group; Drug: Ketamine plus magnesium group; Drug: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04095455

N10-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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. .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

pectoral nerves block group

Active Comparator group

Description:

modified pectoral nerves block was performed on the side of surgery

Treatment:

Procedure: pectoral nerves block group

Ktamine plus Magnesium group

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine plus magnesium group

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: Control group