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.: PACTR201608001744344 Date of Approval: 19/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ondansetron versus lornoxicam intravenous regional anesthesia
Official scientific title Ondansetron versus lornoxicam as adjuvants to intravenous regional anesthesia (IVRA) in patients undergoing hand and forearm surgery
Brief summary describing the background and objectives of the trial Intravenous regional anaesthesia (IVRA) was ¿rst described in 1908 for anaesthesia of the hand and forearm by August Karl Gustav Bier 1 . It is easy to administer, reliable and cost-effective for short operative procedures of extremities performed on an ambulatory basis 1,2 . Different additives have been combined with local anaesthetics (LAs) to improve block quality, prolong post-de¿ation analgesia, and decrease tourniquet pain 1-4. Ondansetron, a speci¿c 5-hydroxytryptamine-3 (5-HT3) antagonist, is widely used as an antiemetic drug 5 and has a well de¿ned and minor side-effect pro¿le. The 5- HT3 antagonists interfere with peripheral serotonin effects on nociception 6 . Ondansetron exhibits local anaesthetic properties 7. Ondansetron has demonstrated binding at the opioid m receptors in humans and exhibits agonist activity 8 . Ondansetron has been shown to be successful in decreasing pain associated with injection of propofol 9 and rocuronium 10 with the added advantage of preventing postoperative nausea and vomiting. Lornoxicam is a new NSAID of the oxicam class with analgesic, anti-in¿ammatory and antipyretic properties which is available in oral and parenteral form 11. The aim of this study is to compare the effects of adding either ondansetron or lornoxicam to intravenous regional anesthesia (IVRA) in patients undergoing hand and forearm surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anesthesia and postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
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
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31045/07/16 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
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 control group ( C ) IVRA with 3 mg/kg lidocaine 2% diluted with saline to a total volume of 40 ml. once Intravenous regional anaesthesia 30 Active-Treatment of Control Group
Experimental Group Ondansetron group ( O ) IVRA with 3 mg/kg lidocaine 2% plus 4 mg ondansetron diluted with saline to a total volume of 40 ml once Intravenous regional anaesthesia 30
Experimental Group Lornoxicam group ( L ) IVRA with 3 mg/kg lidocaine 2% plus 8 mg Lornoxicam diluted with saline to a total volume of 40 ml once Intravenous regional anaesthesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 ¿ 60 years either gender ASA I-II undergoing hand and forearm surgeries Patients with Raynaud disease sickle cell anaemia a history of any drug allergy 18 Year(s) 60 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 onset time of sensory and motor block assessed every 30 seconds from drug solution injection till complete sensory and motor block is achieved
Primary Outcome Tourniquet pain is assessed by visual Analogue Scale (VAS) 5 min, 10 min, 15 min, 20 min, 30 min after tourniquet inflation
Primary Outcome Sensoryand motor recovery time when occurs
Secondary Outcome total intra-operative fentanyl consumption at the end of surgery
Secondary Outcome postoperative pain (VAS) 5min (T0), 30 min (T1), 1hr (T2), 2hr (T3), 4hr (T4) , 6hr (T5), 12hr (T6) and 24hr (T7) after deflation of the tourniquet
Secondary Outcome The time of 1st analgesic requirement when occurs
Secondary Outcome total consumption of pethidine once 24 h postoperative
Secondary Outcome Intra-operative or postoperative complications if occured
Secondary Outcome 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 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
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical 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 surgical 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 surgical ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information