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.: PACTR201211000450183 Date of Approval: 06/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A RANDOMISED CONTROLLED TRIAL COMPARING THE EFFECT OF ADJUVANT INTRATHECAL 2MG MIDAZOLAM TO 20-MICROGRAMMES FENTANYL ON POST OPERATIVE PAIN FOR PATIEN
Official scientific title A RANDOMISED CONTROLLED TRIAL COMPARING THE EFFECT OF ADJUVANT INTRATHECAL 2MG MIDAZOLAM TO 20-MICROGRAMMES FENTANYL ON POST OPERATIVE PAIN FOR PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERY UNDER SPINAL ANESTHESIA
Brief summary describing the background and objectives of the trial Intrathecal adjuvants are added to local anaesthetics to improve the quality of neuraxial blockade and prolong the duration of analgesia during spinal anaesthesia. As an intrathecal adjuvant, fentanyl improves the onset and quality of spinal blockade as compared to plain bupivacaine and confers a short duration of postoperative analgesia. However, its use is associated with several adverse effects that range from pruritus to life threatening respiratory depression. Intrathecal midazolam as an adjuvant has been used and shown to improve the quality of spinal anaesthesia and prolong the duration of postoperative analgesia. No studies have studies have been done comparing intrathecal fentanyl with bupivacaine and intrathecal 2mg midazolam with bupivacaine. Objective To compare the effect of intrathecal 2mg midazolam to intrathecal 20 micrograms fentanyl when added to 2.6 ml of 0.5% hyperbaric bupivacaine, on post-operative pain, in patients undergoing lower limb orthopaedic surgery under spinal anaesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,post-operative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/11/2012
Actual trial start date
Anticipated date of last follow up 31/01/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Midazolam group single dose 2mg intrathecal midazolam stat Intrathecal administration adjuvant 2mg midazolam to 2.6mls of 0.5% heavy bupivacaine 20
Control Group Fentanyl group 20microgrammes intrathecal fentanyl stat Intrathecal administration adjuvant 20microgrammes fentanyl to 2.6mls of 0.5% heavy bupivacaine 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II patients scheduled for lower limb orthopaedic surgery 1. Patient refusal 2. Patients <18years and >76years 3.Failure to reach the sub arachnoid space and converted to GA 4.Patients with contraindications to neuraxial anaesthesia Puncture site infection Hypovolemic shock c. Coagulopathy d. Sepsis 5. Patients with psychological / mental instability 6. Patients with known psychiatric condition 7. Patient involved in any other clinical studies 18 Year(s) 75 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 09/10/2012 Aga Khan University Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3rd parklands avenue Nairobi 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to first request of analgesia following surgery Hourly monitoring of visual analog pain score, blood pressure heart rate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd parklands avenue, Nairobi Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital 3rd parklands avenue, Nairobi Nairobi 30270-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Hospital 3rd parklands avenue, Nairobi Nairobi 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr Thikra Sharrif 3rd parklands avenue, Nairobi Nairobi 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Codero Fcodero@yahoo.com +254722449575 3rd parklands avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Resident Anaesthessiology
Role Name Email Phone Street address
Public Enquiries Francis Codero Fcodero@yahoo.com +254722449575 3rd parklands avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Prin
Role Name Email Phone Street address
Scientific Enquiries Francis Codero Fcodero@yahoo.com +254722449575 3rd parklands avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Principal investigator
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information