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.: PACTR201907659337128 Date of Approval: 12/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Opioid Free versus Opioid Based Anaesthesia on Breast Cancer Pain Score and Immune Response
Official scientific title The Effect of Opioid Free Versus Opioid Based Anaesthesia on Breast Cancer Pain Score and Immune Response
Brief summary describing the background and objectives of the trial Evidence-based multimodal opioid-sparing analgesia has become an alternative to managing post-surgical pain in the last two decades. Opioid free anaesthesia (OFA) reduces the need for postoperative opioids in the PACU, reduces postoperative hypertension and desaturation and improves the Visual Analogue Scale (VAS) and the quality of recovery. There has been a move toward opioid-free anaesthesia (OFA) to achieve the goals of hypnosis with amnesia and sympathetic stability without the adverse effects of opioids. Various methods as regional blocks and drugs such as lignocaine, dexmedetomidine, ketamine, etc., can be employed to preclude the use of opioids.) Studies have shown that when used in conjunction with general anaesthesia can reduce postoperative pain and opioid requirement The aim of this study is to evaluate the effect of opioid-free anaesthesia versus opioid-based anaesthesia in breast cancer patients, undergoing unilateral modified radical mastectomy with axillary clearance, as regards: •Pain intensity using the Visual Analogue Scale (VAS) in the first 24 hours postoperatively. •Screening for post-mastectomy neuropathic pain. •Effect of opioid and surgical stress on the immune system. •Patient outcome including haemodynamic stability, patient satisfaction and occurrence of postoperative complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2019
Actual trial start date 01/08/2019
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/07/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Opioid free anaesthesia group ultrasound (US) guided paravertebral block 30 ml of levobupivacaine 0.25% Postoperative continuous paravertebral catheter infusion and paracetamol if VAS MORE 3 24 hours after surgery then after week postoperative ultrasound (US) guided paravertebral block catheter will be inserted to all patients then induction of GA BY propofol and atracurium 20
Control Group Opioid based anaesthesia group nalbuphine (0.2 mg/kg) Postoperative Nalbuphin (0.1 mg/kg) IV and paracetamol if VAS more 3 24 hours after surgery, then after week postoperative Standard general anaesthesia will be induced by IV nalbuphine propofol and atracurium 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiology (ASA) physical status class I and II. Patient refusal Gastroesophageal reflux disease and history of peptic ulcer. Renal or hepatic impairment. Reconstructive breast surgery, re-do surgery or previous mastectomy of the other breast. Coagulopthies Body Mass Index > 35 kg/m2. Immunosuppressive therapy and immune disorders. Metastasis, radiotherapy or chemotherapy before surgery. Pregnancy. Patients with a psychiatric disorder. History of allergy to local anaesthetics. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 17/01/2019 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Mesalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity using the Visual Analogue Scale (VAS) in the first 24 hours postoperatively. Upon arrival from the operating room and after 30 minutes then every hour in the first four hours and every 4 hours postoperatively for 24 hours
Primary Outcome Screening for post-mastectomy neuropathic pain. One Week post operative
Secondary Outcome Effect of opioid and surgical stress on the immune system. Peripheral blood samples will be withdrawn from all patients preoperatively , 24 hours post operatively and after 7 days from the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anesthesia and Pain Management Medical Research Institute Alexandria University 165 Elhoryea Street Elhadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rana Alsayed Hussam ElDein Aboalsoud 313 takseem el koda street smouha Alexandria 21615 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and Pain Management Medical Research Institute Alexandria University 165 Horreya Avenus Hadara Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Abdel Moneim Arida 17 Champolion St.Azarita Alexandria 21521 Egypt
Laila Abdel Aziz Sabry 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Ahmed Fawzy Elmolla 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Hossam ElDeen Mohammad Ghoneim 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Rana Alsayed Hussam ElDein Aboalsoud 313 takseem el koda street smouha Alexandria 21615 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Arida IMAD.ARIDA@alexmed.edu.eg 00201223129135 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Laila Sabry Lillysabry1@hotmail.com 00201223584610 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information