Postoperative Pain
Conditions
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.
Interventions
PROCEDUREpectoral nerves block group
ultrasound guided block of nerve supply of surgical site
DRUGKetamine 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).
DRUGControl group
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total morphine requirements | 24 hours postoperatively | calculating the total dose of morphine consumed in postoperative analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fentanyl consumption | intraoperative period | Total amount of fentanyl used by the anesthetic provider in the operating room |
| Visual analogue scale score | 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 | 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 | during the first post-operative 24 hours | assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred. |
Countries
Egypt
Outcome results
None listed