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.: PACTR201505001091143 Date of Approval: 31/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of intrathecal nalbuphine on prevention of postspinal shivering after knee arthroscopy
Official scientific title Role of intrathecal nalbuphine on prevention of postspinal shivering after knee arthroscopy
Brief summary describing the background and objectives of the trial Shivering associated with spinal anesthesia is a common and uncomfortable problem and may interfere with monitoring, oxygen consumption and carbon dioxide production. The aim of the study is to evaluate the effect of intrathecal nalbuphine on the prevention of shivering during spinal anesthesia in patients undergoing knee arthroscopy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,nalbuphine, shivering,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2013
Actual trial start date 07/04/2013
Anticipated date of last follow up 29/08/2013
Actual Last follow-up date 29/08/2013
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
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 randomization by computer programe Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine 0.5% 2.5 ml single dose intrathecal 30 Placebo
Experimental Group bupivacaine 0.5%+nalbuphine 400 microgram 2.5 ml single dose intrathecal 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
20-60 years of both sex and ASA(American Society of Anesthesia) physical status I or II scheduled for knee arthroscopy under spinal anaesthesia Patients with contraindications to regional anaesthesia, allergy to the study medication, obese with body mass index (BMI) >30 were excluded. 20 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
No medical ethical comitte of menofiya facculty of medicine
Ethics Committee Address
Street address City Postal code Country
3, yassin abdelghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of shivering 10,20,30,40,50 min postanesthetic giving
Secondary Outcome severity of shivering at end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ayman ebied 3, yassin abdelghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries ahraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries ahraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menoufiya faculty of medicine
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information