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.: PACTR201502001010803 Date of Approval: 25/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title study of the effects of two forms of epidural bupivacaine on postoperative pain following total knee replacement
Official scientific title study of the effects of two forms of epidural bupivacaine on postoperative pain following total knee replacement
Brief summary describing the background and objectives of the trial Postoperative pain after total knee arthroplasty (TKA) was ranked by a broad cross section of patient as their highest concern, highlighting the necessity for prolonged postoperative analgesia. Regional anesthesia has been commonly used as a strategy to mitigate postoperative pain. epidural anesthesia is considered as the gold standard in reliving postoperative pain however prolonged infusions of large amounts of local anesthetic may be accompanied by local anesthetic systemic toxicity. Therefore research have focused on reducing the local anesthetic doses. Bupivacaine is one of the most commonly employed agents in epidural anesthesia and analgesia. However only plain marcaine has been used for this purpose. Hyperbaric marcaine is commonly used for spinal anesthesia because it tends to spread caudally by the effect of its density to avoid total spinal complication however it have not tried for epidural anesthesia. We postulate that the higher density of hyperbaric marcaine would lead to slower diffusion of the anesthetic solution and better block quality than the use of plain marcaine. We hypothesize that the use of hyperbaric bupivacaine (heavy marcaine) in epidural anesthesia would prolong duration of the block, postoperative analgesia and volume of local anesthetic infusion so decreases local anesthetic toxicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/03/2015
Actual trial start date 16/03/2015
Anticipated date of last follow up 10/08/2015
Actual Last follow-up date 11/08/2015
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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 randomized by research randomizer a computer generated program central randomization by phone calls to an anesthesia technician who will not participate in patient care or outcome assessment 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 heavy group heavy marcaine 0.5% bolus dose 8 ml plus 8 ml 2% xylocaine followed after 30 minutes by continuous infusion of 2 ml per hour for 24 hours bolus once while infusion for 24 hours the infusion mixture is prepared as 25 ml 0.5% marcaine plus fentanyl 100 mcg then completing with normal saline till 50 cc the syring will be attached to an infusion pump to infuse 2 ml per hour epidurally for 24 hours 50
Control Group plain group plain marcaine 0.5% bolus dose 8 ml plus 8 ml 2% xylocaine followed after 30 minutes by continuous infusion of 2 ml per hour for 24 hours bolus once while infusion for 24 hours the infusion mixture is prepared as 25 ml 0.5% marcaine plus fentanyl 100 mcg then completing with normal saline till 50 cc the syring will be attached to an infusion pump to infuse 2 ml per hour epidurally for 24 hours 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 2 and 3 patients who will undergo one side total knee replacement age from 50 to 80 , both male and female ASA 4 patients patients who are receiving anti platelets till the operation day. patients with coagulopathies patients with sever back deformities or infection at the planned site of epidural hemodynamically unstable patients with poor systolic function. 50 Year(s) 80 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 27/10/2014 Menoufiya universty
Ethics Committee Address
Street address City Postal code Country
Gamal Abdelnasser street Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score visual analogue 10 point score 0 (immidiatly after operation) 1/2 hour, 1 hour, 2 hours, 6 hours,12 hours,24 hours and 48 hours postoperatively
Primary Outcome first request for analgesia the time when the patient first reports pain.
Secondary Outcome sensory block onset and duration will be assessed by pin prick onset will be assessed 5 minutes, 10 minutes 15 minutes after epidural bolus injection. Duration of sensory anesthesia is the time elapsed till return of sensation.
Secondary Outcome motor block onset and duration onset of motor block will be assessed 5,10,15 minutes after the bolus complete motor block inability to move legs or partial weakness the degree of block will be assessed by Bromage scale. the time from onset toreturn of motor power is the duration of motor block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university gamal abdelnasser street shebin Elkom NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya university gama abdelnasser street shebin Elkom NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya university gama abdelnasser street shebin Elkom NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
hazem elsersy 89 saad zagloul street shebin Elkom NA Egypt
Magdy chehata Ain shams Cairo NA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem elsersy hazelsersy@hotmail.com 00201091096655 89 saad zagloul street
City Postal code Country Position/Affiliation
shebin elkom n a Egypt lecturer of anesthesia menoufiya university
Role Name Email Phone Street address
Public Enquiries Magdy chehata magdychehata@yahoo.com 00966563386721 ain shams
City Postal code Country Position/Affiliation
cairo na Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hazem elsersy hazelsersy@hotmail.com 00201091096655 89 saad zagloul street
City Postal code Country Position/Affiliation
shebin elkom na Egypt lecturer of anesthesia menoufiya university
REPORTING
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