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

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: pectoral nerves block group; Drug: Ketamine plus magnesium group; Drug: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al haram, Giza, Egypt, 12555
      • Recruiting
      • National Cancer Institute
      • Contact: Ahmed S Ahmed, MD; Phone Number: +20 01098426689; Email: Dr_mido12@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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. .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2017
• Primary Completion (Anticipated): March 11, 2021
• Study Completion (Anticipated): April 15, 2021

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: N10-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No