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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095455
• Other study ID #: N10-2017
• Status: Recruiting
• Phase: Phase 3
• Start date: November 12, 2017
• Est. completion date: April 15, 2021

Study information

• Verified date: October 2020
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 15, 2021
• Est. primary completion date: March 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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. .

Related Conditions & MeSH terms

• Pain, Postoperative
• 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).
• Control group
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Al haram	Giza

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine requirements	calculating the total dose of morphine consumed in postoperative analgesia	24 hours postoperatively
Secondary	fentanyl consumption	Total amount of fentanyl used by the anesthetic provider in the operating room	intraoperative period
Secondary	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.
Secondary	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.
Secondary	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