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.: PACTR201704002155170 Date of Approval: 30/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic efficacy of Tenoxicam,Nalbuphine and Magnesium sulphate as adjuvant to intraarticular Levobupivacaine in knee art
Official scientific title A comparative study of the analgesic efficacy of Tenoxicam,Nalbuphine and Magnesium sulphate as adjuvant to intraarticular Levobupivacaine in knee arthroscopy
Brief summary describing the background and objectives of the trial No previous study compared the analgesic efficacy of tenoxicam,nalbuphine and magnesium sulphate as adjuvant to intraarticular levobupivacaine in knee arthroscopy. Aim of the study: The aim of this study is to compare the analgesic efficacy of tenoxicam,nalbuphine and magnesium sulphate as adjuvant to intraarticular levobupivacaine for preventive analgesia in knee arthroscopy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied knee arthroscopy,Musculoskeletal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 01/10/2017
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GLT (n=30):will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg GLT (n=30):will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg postsurgical GLT (n=30):will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg 30
Experimental Group GLN(n=30) will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg GLN(n=30) will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg postsurgucal GLN(n=30) will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg 30
Experimental Group GLM(n=30) will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate GLM(n=30) will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate postsurgical GLM(n=30) will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate 30
Control Group GL receive 20 ml levobupivacaine 0.5% postsurgical receive 20 ml levobupivacaine 0.5% 40 Active-Treatment of Control Group
Experimental Group GLT :will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg GLT :will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg postsurgical GLT will receive 20 ml levobupivacaine 0.5% and tenoxicam 20mg 40
Experimental Group GLN will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg GLN will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg postsurgucal GLN will receive 20 ml levobupivacaine 0.5% and nalbuphine 0.1 mg/kg 40 Active-Treatment of Control Group
Experimental Group GLM will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate GLM will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate postsurgical GLM(n=30) will receive 20 ml levobupivacaine 0.5% and 500 mg magnesium sulphate 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Male patients -Age 18-50 years Patients will be excluded from the study if they had sickle cell disease, peripheral vascular disease, history of DVT, poorly controlled hypertension, history of allergy to the studied drug, treatment for chronic pain alcohol and substance addiction chronic use of NSAID, opiates 18 Year(s) 50 Year(s) Male
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
No 29/03/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
BeniSuief University hospital,Egypt BeniSuief ,Egypt 000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be NRS at passive motion at 4 hours postoperative. The primary outcome will be NRS at passive motion at 4 hours postoperative.
Secondary Outcome -Postoperative time to first request of analgesics (minutes) -Postoperative time to first request of analgesics (minutes)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
(The FM-BSU REC) benisuef benisuef 000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding benisuef BeniSuief Egypt 000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hatem Elmoutaz BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hatem Elmoutaz BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
doaa rashwan ,Egypt giza 000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Elmoutaz doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt
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