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.: PACTR201711002797317 Date of Approval: 23/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Increasing The Dose of Nalbuphine As AN Adjuvant To Local Anesthetic In Paravertebral Block In Mastectomies.A Randomised Double Blinded Stud
Official scientific title Effect of Increasing The Dose of Nalbuphine As AN Adjuvant To Local Anesthetic In Paravertebral Block In Mastectomies.A Randomised Double Blinded Study
Brief summary describing the background and objectives of the trial Breast cancer is perhaps the most common cancer in women that requires frequent surgery (1). Nearly 40% of postoperative breast surgery patients experience significant acute postoperative pain with a pain score above 5 reflecting the inadequacy of conventional pain management (2). Thoracic paravertebral block (PVB) is used for pain relief after thoracotomy and mastectomy. PVB can provide profound, long-lasting sensory deafferentation. The resulting greater attenuation of surgical stress response may translate into reduced inotropic stress response of the heart. If quality and duration of analgesia of PVB can be improved by adding adjuvants to local anesthetic (LA), its benefits can be maximized (4).Nalbuphine, a derivative of 14-hydroxymorphine is a strong analgesic with mixed k agonist and µ antagonist properties. The analgesic potency of nalbuphine has been found to be equal to morphine but unlike morphine, it exhibits a ceiling effect on respiratory depression(5). Nalbuphine has the potential to maintain or even enhance µ-opioid based analgesia while simultaneously mitigating the µ-opioid side effects(5).It had been used successfully and safely in epidural and intrathecal blocks(5-6).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied breast cancer surgeries mastectomies,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2017
Actual trial start date 02/12/2017
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group(PB) given bubivacaine0.5% 0.3 ml/kg once 20 Active-Treatment of Control Group
Experimental Group Group(PBN 1) will be given bubivacaine0.5% plus 10 mg nalbuphine in 1ml, will be given bubivacaine0.5% plus 10 mg nalbuphine in 1ml, 20
Experimental Group Group(PBN 2) will be given bubivacaine0.5% plus 20 mg nalbuphine in 1ml., once 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty )60( patients American Society of Anesthesiologist (ASA) physical status I/II/III females, aged (18-78) years, undergoing breast surgery will be studied. Exclusion criteria included patients undergoing bilateral breast surgery or breast reconstruction; those having contra-indications for PVB, e.g., patient refusal, infection at injection site, anticoagulant therapy, abnormal coagulation profile, or hypersensitivity to LA; patients on chronic antiemetics or chronic pain medication; pregnant patients; central neuropathy, liver or renal impairment, drug or alcohol abusers, and those with psychiatric illnesses that would interfere with perception and assessment of pain and obese patients with a body mass index (BMI) >30 kg/m2. 18 Year(s) 78 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 15/11/2017 Fayoum University (R 66)
Ethics Committee Address
Street address City Postal code Country
university district Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure was cumulative IV tramadol consumption over 24 h, pain scores at rest and active movement of ipsilateral arm. 15 minutes, 30 minutes and 2, 4, 8, 12 and 24 h
Secondary Outcome Secondary outcome measures will include intraoperative fentanyl requirements, TFR, bradycardia , hypotension, sedation scores, complications ( nausea. vomiting, pruritus), time to mobilize, time to discharge and patient satisfaction. in the first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospitals fayoum university district Fayoum 631514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum university hospitals Fayoum University district Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University hospitals Fayoum University District Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram Botros 105 Toman Bai street Cairo 11321 Egypt
Atef Mohamed Sayed Mahmoud Khalil Fayoum University Hospitals Fayoum 63514 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph makram Botros dr_jo27@yahoo.com 002 01227598825 105 toman bai st, Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt lecturer of Anesthesiology, fayoum university, Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Atef Mohamed Sayed Mygodprotection@yahoo.com 002 01016581609 Fayoum university district
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Lecturer of Anesthesiology , Fayoum University, Faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries joseph makram Botros dr_jo27@yahoo.com 002 01227598825 105 toman bai st, Zeitoun
City Postal code Country Position/Affiliation
Egypt 11321 Egypt lecturer of Anesthesiology, fayoum university, Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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