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.: PACTR201701001980400 Date of Approval: 17/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Single dose local infiltration of analgesia in total knee arthroplasty: Effect on early post operative pain: randomized controlled trial
Official scientific title Single dose local infiltration of analgesia in total knee arthroplasty: Effect on early post operative pain: randomized controlled trial
Brief summary describing the background and objectives of the trial Total knee arthroplasty (TKA) procedures have rapidly increased in number in the last decade and are also performed over a wider age spectrum. Post-operative pain and the treatment thereof especially in the first 24 hours remains a complex issue. Both the public and health professional¿s attitude and expectations of pain and pain control have also changed. Focus has shifted to treating pain aggressively and even preemptively.(15) A multimodal pain approach has become more important for better early pain control. Keisers and Delft did a meta-analysis of 7 RCT's with 405 patients and showed a possible decrease in pain measured on the VAS score in the first 24 hours only as well as decreased opioid use, however due to the high level of heterogeneity could not draw a firm conclusion.(3) The studies varied in the volume injected ranging between 20 ml and 152 ml. Peng Xu and Li did a meta-analysis looking at 18 trial involving 1858 TKA's and showed improved pain scores as well as earlier mobilization. However the administration method as well as the LAI content varied widely. LAI are being used regularly by knee surgeons despite variable results from these studies. The general opinion is that LAI decreases pain, but very few studies have confirmed this.(3) Furthermore there is no standardized method of giving the LAI in terms of concentration, volume and technique. We hypothesize that giving LAI is superior to Placebo, which is saline only. We will be giving weight specific doses of Bupivicaine in a structured technique explained later. Outcomes will be measured using the well validated VAS sheet and opioid consumption.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pain after total knee arthroplasty,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/04/2017
Actual trial start date
Anticipated date of last follow up 05/12/2017
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised used website randomize.com to generate the numbers Using a sealed envelope opened by the anaethetist only and closed again 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 Receiving Normal Saline Injection 150 ml Single dose Local infiltration of soft tissue and skin during the surgical procedure 20 Placebo
Experimental Group Receiving Marcaine and normal Saline 2mg/kg with normal saline to total of 150ml Single dose Local infiltration of soft tissue and skin during the surgical procedure 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients able to sign consent and undergoing a TKA with spinal anaesthesia will be included epidural any drug dependence psychological problems known allergy to any medication in the mixture uncontrolled angina neurological deficits renal insufficiency abnormal liver functions minors. 18 Year(s) 90 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 24/02/2017 Humanresearch ethics committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town 7935 South Africa
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 24/02/2017 HREC
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To measure to pain post operatively using a visual analogue score sheet 6 hours 24 hours
Secondary Outcome Measure amount of Opioids consumed in first 24 hours 6 hours 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Main Rd, Observatory Cape Town 7935 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr S Wever Anzio Road Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Fees Office, Cross Campus Rd, Rondebosch Cape Town 7701 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr M Nortje H49, OMB, GSH, Main Road, Observatory Cape Town 7764 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stefan Wever stefanwever@gmail.com 0845879038 Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa
Role Name Email Phone Street address
Principal Investigator Stefan Wever stefanwever@gmail.com 0845879038 32 Avonduur rd
City Postal code Country Position/Affiliation
Cape Town 7405 South Africa
Role Name Email Phone Street address
Public Enquiries Stefan Wever stefanwever@gmail.com 027845879038
City Postal code Country Position/Affiliation
Pinelands, Cape Town 7405 South Africa Registrar
Role Name Email Phone Street address
Scientific Enquiries Stefan Wever stefanwever@gmail.com 027845879038 32 Avonduur
City Postal code Country Position/Affiliation
Pinelands, Cape Town 7405 South Africa Registrar
REPORTING
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Result URL Hyperlinks Link To Protocol
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