Clinical trial NCT04095455: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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. .

Primary outcomes:
measure: total morphine requirements
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: fentanyl consumption
timeFrame: intraoperative period
measure: Visual analogue scale score
timeFrame: immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.
measure: Sedation score
timeFrame: A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.
measure: Nausea and vomiting
timeFrame: during the first post-operative 24 hours
Other outcomes:
Locations:
city: Al haram
country: Egypt
facility: National Cancer Institute
state: Giza
Study officials:
References: