Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001746591 Date of Approval: 20/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ondansetron femoral nerve block
Official scientific title Ondansetron as an adjuvant to ultrasound guided femoral nerve block for postoperative analgesia after arthroscopic anterior cruciate ligament reconstruction.
Brief summary describing the background and objectives of the trial Anterior cruciate ligament reconstruction (ACLR) is recognized as a painful procedure requiring intensive postoperative analgesia . Femoral nerve blocks (FNB) have been shown to significantly improve postoperative analgesia compared with systemic opioid therapy, and it may even reduce hospital length of stay after knee procedures 2,6,7 . Therefore, FNB was commonly added to general or centroxial anesthesia to achieve adequate pain control after ACLR 8 . Ondansetron, a speci¿c 5-hydroxytryptamine-3 (5-HT3) antagonist, is widely used as an antiemetic drug 9 and has a well de¿ned and minor side-effect pro¿le. The 5- HT3 antagonists interfere with peripheral serotonin effects on nociception 10 . Ondansetron exhibits local anaesthetic properties 11. Ondansetron has demonstrated binding at the opioid m receptors in humans and exhibits agonist activity 12 . Ondansetron has been shown to be successful in decreasing pain associated with injection of propofol 13 and rocuronium 14 with the added advantage of preventing postoperative nausea and vomiting. The aim of this study is to assess the effects of adding ondansetron to femoral nerve block as postoperative analgesia after arthroscopic anterior cruciate ligament reconstruction (ACLR).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2016
Actual trial start date 01/07/2016
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date 04/05/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31044/07/16 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
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 randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ultrasound guided femoral nerve block : control group(C): 15 ml bupivacaine 0.25%. once at the end of surgical procedure femoral nerve block 30 Active-Treatment of Control Group
Experimental Group Group II : ondansetron group ( O ) bupivacaine 0.25 % plus 4 mg ondansetron ( 2 mg/ ml ). once at the end of surgical procedure femoral nerve block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 ¿ 40 years either gender ASA I-II undergoing elective arthroscopic anterior cruciate ligament reconstruction (ACLR) body mass index > 35 mental disorders any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality, or patient refusal) known allergy to the study drug pregnancy drug or alcohol abuse a daily intake of opioid analgesics 18 Year(s) 40 Year(s) Both
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 01/07/2016 Tanta University, Faculty of Medicine, research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue score of pain VAS 0 (immediately after transport to PACU) 2 4 6 12 24 h .
Secondary Outcome ¿ Time of first analgesic request when occurs
Secondary Outcome ¿ Total consumption of rescue analgesia 24 h postoperative
Secondary Outcome ¿ Postoperative mean arterial blood pressure, heart rate 0 (immediately after transport to PACU) 2 4 6 12 24 h .
Secondary Outcome ¿ Any concomitant events like nausea; vomiting, shivering, pruritus or respiratory complications if occured
Secondary Outcome ¿ The overall patient satisfaction 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Anesthesia and Surgical ICU, Tanta University 10 Algeish street Tanta Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Gehan Morsy Eid 7 Tharwat Street, Hassan Radwan Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
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