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

NCT04095455 | Unknown Phase 3

• 1 other identifier: N10-2017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• total morphine requirements

  calculating the total dose of morphine consumed in postoperative analgesia

  24 hours postoperatively

Secondary Outcomes (4)

• fentanyl consumption

  intraoperative period

• Visual analogue scale score

  immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.

• Sedation score

  A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.

• Nausea and vomiting

  during the first post-operative 24 hours

Study Arms (3)

pectoral nerves block group

ACTIVE COMPARATOR

modified pectoral nerves block was performed on the side of surgery

Procedure: pectoral nerves block group

Ktamine plus Magnesium group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Drug: Control group

Interventions

pectoral nerves block group PROCEDURE

ultrasound guided block of nerve supply of surgical site

pectoral nerves block group

Ketamine plus magnesium group DRUG

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).

Ktamine plus Magnesium group

Control group DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. .

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Al Haram, Giza Governorate, 12555, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and pain medicine

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: September 19, 2019
• Study Start: November 12, 2017
• Primary Completion: March 11, 2021
• Study Completion: April 15, 2021
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

EG (1)