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.: PACTR201509001245595 Date of Approval: 23/08/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title preincional analgesia with infiltration of levobupivacaine versus ketamine
Official scientific title efficacy of preincional analgesia with subcutaneous infiltration with levobupivacaine versus ketamine in patients undergoing abdominal hysterectomy under general anesthesia.
Brief summary describing the background and objectives of the trial Postoperative analgesia is one of the important factors in patient recovery. Release of proteolytic and inflammatory mediators after surgical trauma generate powerful nociceptive impulses that trigger pain. The aim of this trial is to assess the effect of preincisional infiltration of ketamine on amelioration of postoperative pain following abdominal hysterectomy as compared with levobupivacaine infiltration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied abdominal hysterectomy,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2015
Actual trial start date 01/09/2015
Anticipated date of last follow up 20/11/2015
Actual Last follow-up date 20/11/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 using randomization table from a statistics book 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
Experimental Group ketamine group 1mg/kg once once subcutaneous infiltration of ketamine 25 Active-Treatment of Control Group
Control Group control group 20 ml levobupivacaine once once subcutaneous infiltration of 20 ml of levobupivacaine before skin incision 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II 30-60 years Elective abdominal hysterectomy General anesthesia 120 min procedure Allergy to the study drugs Cardiovascular disease Hepatic and renal failure Refusal Spinal anesthesia 30 Year(s) 60 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 20/08/2015 anesthesiology department approval
Ethics Committee Address
Street address City Postal code Country
Kasr Al ainy st Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score 0 2 4 6 8 10 12 24 hours
Secondary Outcome hemodynamic 0 2 4 6 8 10 12 24 hours
Secondary Outcome total dose of analgesic 24 hours
Secondary Outcome PONV 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university hospital Kasr al ainy st Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university hospitals Kasr al ainy st Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university hospitals Kasr al ainy st Cairo 11562 Egypt Hospital
Secondary Sponsor Cairo university hospitals Kasr al ainy st Cairo 11562 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
atef Kamel Kasr al ainy st Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Kamel atef.kamel@kasralainy.edu.eg +201224616643 Kasr alainy
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Nasr seif sief.nasr@yahoo.com +201001155851 Kasr Al ainy st
City Postal code Country Position/Affiliation
cairo 11562 Egypt MD degree Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Atef Salama atef.kamel@kasralainy.edu.eg +201001155851 Kasr Al ainy st
City Postal code Country Position/Affiliation
cairo 11562 Egypt MD degree Lecturer of anesthesia
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