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.: PACTR201705002266194 Date of Approval: 05/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postmastectomy Pain
Official scientific title The pre-emptive use of pregabalin may reduce the incidence of postmasectomy pain syndrome following breast cancer surgery: a comparitive study
Brief summary describing the background and objectives of the trial Chronic postmastectomy pain syndrome (PMPS)is mainly achronic post-surgical neuropathic paindisorder that follows breast cancer procedures.The underlying pathophysiological mechanisms of PMPS are high complex and entangle both peripheral and central sensitization.Pain due to PMPS could be severe enough to induce long term disabiliy, interfere with sleep and perforance of daily activity. Use of the affected arm may be greatly distrubed due to associated lymphedema and frozen shoulder resulting in poor quality of patient's life. Pregabalin is an orally administered gamma- amino-butyric acid analong that has similar pharmacology to its pro-drug gabapentin, with anticonvulsant, anxiolytic, analgesic and sleep modifying actions. Its efficacy is proven in many neuropathic pain syndromes such as diabetic peripheral neuropathy, postherpatic neuralgia and fibromyalgia.Aim of the work in this prospective,randomized, double blinded, placebo-controlled comparative study has been done in the NCI-Cairo University. Our hypothesis isto estimate the assumed efficacy of early perioperative use of pregabalin(75mg every 12 hours starting 1 hour before surgery and for 7 days) on the prevalence of this confronting challenging PMPS with 6 months follow up period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,post-mastectomy, pain , pregabalin, cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/09/2015
Actual trial start date 07/12/2015
Anticipated date of last follow up 23/08/2016
Actual Last follow-up date 27/10/2016
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 200
Recruitment status Stopped early/ terminated
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 randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group 1 (lyrica group) pregabalin (lyrica) Pfizer,New York NY 75 mg is given to patients with a snip of water 1hour prior to induction of anaesthesia and repeated 12 hours thereafter every 12 hours for 7 days Pfizer,New York NY 75 mg is given to patients with a snip of water 1hour prior to induction of anaesthesia and repeated 12 hours thereafter 100
Control Group group 2 (control group) placebo drug (vitamin B complex) 1 hour before induction of anesthesia then repeated every 12 hour for 7 days (vitamin B complex) 1 hour before induction of anesthesia then repeated every 12 hour 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective breast surgery {either modified radical mastectomy(MRM) or conservative breast surgery (CBS)}combined with axillary dissection. ASA physical status I-II-III -History of pregabalin or gabapentin allergy. -History of allergy to NSAIDs, morphine and paracetamol. -Pregnancy and lactation. -BMI > 40 kg/m^2. -Patients with major liver, renal, cardiorespiratory,endocrinal or haematological disorder. -Patients with preexisting pain which necessitates morphine at daily dose of 30 mg or more (or equivalent opioids). History of pregabalin intake in the preceding 3 months. -History of drug abuse. -Expected another breast surgery in the subsequent period. -Neuropsychiatric disorder. 18 Year(s) 60 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 19/02/2015 Institutional review board at National Cancer Institute
Ethics Committee Address
Street address City Postal code Country
Kasr El-Eini Street, Fomm El Khalig Cairo 11435 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain by using VAS 4 weeks 12 weeks 24 weeks
Secondary Outcome Post-mastectomy neuropathic pain using DN4 4 weeks 12 weeks 24 weeks
Secondary Outcome Side effects of pregabalin 4 weeks 12 weeks 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Cairo Univeresity 1st Settlement Breast Hospital Cairo 11825 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Cancer Institute Kasr El-Eini Street Cairo 11435 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Cancer Institute Kasr El-Eini Street Cairo 11435 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
cairo university El Nahda Square Giza 11435 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Omran azzaomran67@gmail.com +201005246210 312, El-Yasmine 8, First Settlement, New Cairo
City Postal code Country Position/Affiliation
Cairo 11825 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Raafat Mahfouz dr_raafat2006@hotmail.com +201227411245 El haram Street
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Kamel mkamel_76@hotmail.com +201001178479 18 Sawaf Street, 10th Area, Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia NCI, Cairo University
REPORTING
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