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.: PACTR201707002376424 Date of Approval: 26/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Ultrasound guided PECS block with Magnesium sulfate
Official scientific title Efficacy of Ultrasound guided PECS block with Magnesium sulfate
Brief summary describing the background and objectives of the trial Background: Worldwide, breast cancer is the main common cancer among female. In the United State, it affects one in eight women during their lifespan In cancer breast surgery, chronic pain can be developed from badly managed acute post operative pain.we aimed from the study to use a safe ,easy and less complicated method of regional block for reducing the postoperative pain after mastectomy and this will reduce the incidence of chronic postmastectomy pain.patients and metods: 90 adult female with patients physical status ASA classes I , II and III. Patients were allocated randomly into 3 groups Group C, had general anesthesia, Group B, had ultrasound guided PECS block (20ML 0.25% bupivacaine+10ml normal saline) plus general anesthesia and Group M, had ultrasound guided PECS (total 20 ml of Bupivacaine 0.25%+ 1g magnesium sulfate /10ml) plus general anesthesia. Result :As regards the intraoperative fentanil(ug) used was significantly lower in group B(110.4 ± 26.3) and M(108.7±14.1) than in group C(214.3 ± 20.1) and also the same as regards the total poatoperative pethidine(mg) C (220±25.5), B (100.6±24.3) and M(52.3±12.3). The group M was the least group suffered from post operative pain at all times of measurment conclusion:we conclude that PECS block reduce the intraoperative narcotics and produce post-operative pain-free with reduced post- operative narcotics demands, magnesium sulfate extends the duration of pain free
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,POSTOPERATIVE MASTECTOMY PAIN,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 26/05/2015
Actual trial start date 23/06/2015
Anticipated date of last follow up 19/10/2016
Actual Last follow-up date 16/11/2016
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group C giving general anesthesia alone 30 Active-Treatment of Control Group
Experimental Group Group B duration of the study general anesthesia plus PECS block 30
Experimental Group Group M duration of the study general anesthesia plus PECS block with magnesium sulfate 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
90 adult female with patients physical status ASA classes I , II and III, Exclusion criteria included refusal of the patients, contraindications to regional anesthesia (including coagulopathy and local infection, fungating breast cancer), history of allergy to the medications used in the study, patient with history of drug abuse, prior breast surgery except for diagnostic biopsies, and history of treatment for a chronic pain condition, and/or psychiatric disorder. 20 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 24/05/2015 menoufia faculty of medicine ethical comittee
Ethics Committee Address
Street address City Postal code Country
gamal abd el naser Menoufia 21611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study aimed to compare the intraoperative hemodynamic changes, postoperative analgesia, postoperative sedation, and postoperative side effects of the PECS procedure with and without Magnesium sulfate Intraoperative every 15 minutes until the end of operation, on arrival to PACU, 1,2, 3, 6, 12 and 24hours in the surgical ward
Secondary Outcome to improve the postoperative outcome and this will reduce the postoperative complication on arrival to PACU, 1,2, 3, 6, 12 and 24hours in the surgical ward
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine , Menoufia University Gamal abd el naser street Menoufia 21611 Egypt
anesthesia department Menoufia University hospitals Gamal abd el naser street Menoufia 21611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine Gamal abd el naser street Menoufia 21611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine,Menoufia university Gamal abd el naser street Menoufia 21611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
AHMED ABDELAZIZ 29 el essawy street Alexandria 21611 Egypt
Hatem B Abo Elwafa el essawy street Alexandria 21611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AHMED AHMED azizahmed152@hotmail.com 00201221345154 29 el essawy street
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt lecturer of anesthesia, Menoufia university
Role Name Email Phone Street address
Public Enquiries Hatem Abo el wafa hatem_wafa@hotmail.com 00201155497711 el essawy steer
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt lecturer of anesthesia, Menoufia university
Role Name Email Phone Street address
Scientific Enquiries AHMED AHMED azizahmed152@hotmail.com 01221345154 29 el essawy street
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt lecturer of anesthesia, Menoufia university
REPORTING
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