Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003034110 Date of Approval: 31/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium infiltraion for mastectomy
Official scientific title Magnesium Sulphate infiltration for postoperative analgesia following mastectomy. A randomized controlled trial.
Brief summary describing the background and objectives of the trial Breast cancer is the most prevalent cancer among Egyptian women as it represents 32.04% of all cancers according to the latest epidemiologic study, with an expected 20% increase in number of patients by year 2020. Modified Radical Mastectomy(MRM) entails extensive tissue dissection with axillary lymph node evacuation resulting in significant acute postoperative pain in about 40% of patients.Wound infiltration with local anesthetics is important in multimodal analgesia. Unfortunately the analgesic effect is related to the local anesthetics duration of action, approximately 4¿8 h in case of bupivacaine or ropivacaine. Magnesium plays a major role in antinociception as it is a naturally occurring calcium competitor and a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors. Studies have shown better postoperative analgesia when magnesium was administered directly to the surgical area compared to systemic administration. We hypothesized that infiltrating magnesium in pectoralis major muscle would greatly improve functional recovery following MRM especially during arm movement compared to local anesthetic wound infiltration alone. ¿Our primary objective was to assess acute postoperative pain at rest and during arm movement. Secondary objectives included quality of analgesia based on time to first demand for rescue analgesia, number of analgesic demands, 24h cumulative analgesic consumption, nausea and vomiting, wound hematoma or any complication during the 24 hour observation period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,postoperative pain management following mastectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date 31/01/2018
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group M 1000mg magnesium sulfate 10 ml of 10% solution in pctoralis major muscle + 40ml of 0.25% bupivacaine for wound infilteration at end of operation,prior to skin closure infiltration in fibers and pectoral head of pectoralis major muscle. 35
Experimental Group Group B 40ml of bupivacaine 0.25%for wound infilteration,10ml 0.9% saline for pectoralis infilteration. at end of operation,prior to skin closure Bupivacaine local infiltration at edges of wound, placebo at pectoralis major muscle. 35
Control Group Group C 40 ml saline for wound infilteration, 10 ml saline for pectoralis major muscle infilteration at end of operation,prior to skin closure Saline local infiltration at edges of wound, saline at pectoralis major muscle. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Society of Anesthesiologists physical status I and II females. -scheduled for unilateral MRM for breast cancer. -aged 30-65 years, -Patients with known allergy to bupivacaine or magnesium. -History of chronic analgesic drug use. -On treatment with antidepressants, antiepileptics, sedatives or hypnotics for any reason. -Patients receiving chemotherapy or radiotherapy before surgery. -Presence of active malignancy elsewhere were also excluded. 30 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/12/2016 Minia university ethical committee
Ethics Committee Address
Street address City Postal code Country
Main Road - Shalaby Land minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess acute postoperative pain at rest and during arm movement 2 hr 4 hr 6 hr 12 hr 24 hours
Secondary Outcome quality of analgesia based on time to first demand for rescue analgesia, number of analgesic demands, 24h cumulative analgesic consumption, nausea and vomiting, wound hematoma or any complication during the 24 hour observation period. 2 hr 4 hr 6 hr 12 hr 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia university hospital corniche El Nile st. Minia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department minia university Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr wegdan abd rahman minia university,Corniche el Nile minia 61519 Egypt
Dr Khaled Ahmed Abdou Corniche el Nile, Minia university hospital Minia 61519 Egypt
Dr. Medhat M Soliman Minia Oncology center Minia 61519 Egypt
Dr. Medhat M Soliman Minia Oncology center, Corniche el nile Minia 61519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sohair megalla Sohair.Adeeb@mu.edu.eg +20 01200036447 anesthesia department, minia university
City Postal code Country Position/Affiliation
minia 61519 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Wegdan Ali wegdan21122000@yahoo.com +20 01002522558 Corniche el nile, minia university hospita
City Postal code Country Position/Affiliation
minia 61519 Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Khaled Abdou khaledah55@gmail.com +20 01150397419 Corniche el nile, minia university hospita
City Postal code Country Position/Affiliation
minia 61519 Egypt Assisstant professor of anesthesia
REPORTING
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