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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
pectoral nerves block group
Ketamine plus magnesium group
Control group
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. .

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

pectoral nerves block group

Ktamine plus Magnesium group

Control Group

Arm Description

modified pectoral nerves block was performed on the side of surgery

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

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

Outcomes

Primary Outcome Measures

total morphine requirements
calculating the total dose of morphine consumed in postoperative analgesia

Secondary Outcome Measures

fentanyl consumption
Total amount of fentanyl used by the anesthetic provider in the operating room
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.
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.
Nausea and vomiting
assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred.

Full Information

First Posted
June 28, 2019
Last Updated
October 24, 2020
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04095455
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2017 (Actual)
Primary Completion Date
March 11, 2021 (Anticipated)
Study Completion Date
April 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pectoral nerves block group
Arm Type
Active Comparator
Arm Description
modified pectoral nerves block was performed on the side of surgery
Arm Title
Ktamine plus Magnesium group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo
Intervention Type
Procedure
Intervention Name(s)
pectoral nerves block group
Intervention Description
ultrasound guided block of nerve supply of surgical site
Intervention Type
Drug
Intervention Name(s)
Ketamine plus magnesium group
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
Primary Outcome Measure Information:
Title
total morphine requirements
Description
calculating the total dose of morphine consumed in postoperative analgesia
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
fentanyl consumption
Description
Total amount of fentanyl used by the anesthetic provider in the operating room
Time Frame
intraoperative period
Title
Visual analogue scale score
Description
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.
Time Frame
immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.
Title
Sedation score
Description
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.
Time Frame
A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.
Title
Nausea and vomiting
Description
assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred.
Time Frame
during the first post-operative 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. .
Facility Information:
Facility Name
National Cancer Institute
City
Al haram
State/Province
Giza
ZIP/Postal Code
12555
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed S Ahmed, MD
Phone
+20 01098426689
Email
Dr_mido12@yahoo.com

12. IPD Sharing Statement

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

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