The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Analgesic Profile In Breast Cancer Surgeries
NCT ID: NCT04095455
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
75 participants
INTERVENTIONAL
2017-11-12
2021-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pectoral nerves block group
modified pectoral nerves block was performed on the side of surgery
pectoral nerves block group
ultrasound guided block of nerve supply of surgical site
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
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
Control group
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pectoral nerves block group
ultrasound guided block of nerve supply of surgical site
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients' age from18 to 65 Years.
* Body mass index (BMI) are from 20 to 40 kg/m2.
Exclusion Criteria
* 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. .
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute, Egypt
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Salah Ahmed Abd Elgalil
Lecturer of Anesthesia and pain medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Institute
Al Haram, Giza Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N10-2017
Identifier Type: -
Identifier Source: org_study_id