English
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

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

Only registered users can translate articles
Log In/Sign up
The link is saved to the clipboard
StatusRecruiting
Sponsors
National Cancer Institute, Egypt

Keywords

Abstract

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.

Dates

Last Verified: 01/31/2020
First Submitted: 06/27/2019
Estimated Enrollment Submitted: 09/16/2019
First Posted: 09/18/2019
Last Update Submitted: 02/23/2020
Last Update Posted: 02/25/2020
Actual Study Start Date: 11/11/2017
Estimated Primary Completion Date: 08/10/2020
Estimated Study Completion Date: 09/14/2020

Condition or disease

Postoperative Pain

Intervention/treatment

Procedure: pectoral nerves block group

Drug: Ktamine plus Magnesium group

Drug: Control Group

Phase

Phase 3

Arm Groups

ArmIntervention/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: 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 (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.

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersYes
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. .

Outcome

Primary Outcome Measures

1. total morphine requirements [24 hours postoperatively]

calculating the total dose of morphine consumed in postoperative analgesia

Secondary Outcome Measures

1. fentanyl consumption [intraoperative period]

Total amount of fentanyl used by the anesthetic provider in the operating room

2. 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.

3. 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.

4. 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.

Join our facebook page

The most complete medicinal herbs database backed by science

  • Works in 55 languages
  • Herbal cures backed by science
  • Herbs recognition by image
  • Interactive GPS map - tag herbs on location (coming soon)
  • Read scientific publications related to your search
  • Search medicinal herbs by their effects
  • Organize your interests and stay up do date with the news research, clinical trials and patents

Type a symptom or a disease and read about herbs that might help, type a herb and see diseases and symptoms it is used against.
*All information is based on published scientific research

Google Play badgeApp Store badge