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.: PACTR201907657139393 Date of Approval: 01/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Patient-reported outcomes after femoral nerve block versus periarticular injections in patients undergoing total knee arthroplasty: A randomized Controlled study
Official scientific title Patient-reported outcomes after femoral nerve block versus periarticular injections in patients undergoing total knee arthroplasty: A randomized Controlled study
Brief summary describing the background and objectives of the trial Background: total knee arthroplasty (TKA) is one of the most advanced surgical solution for pain relief and mobility improvement in patients with end stage osteoarthritis (1). As the number of TKAs performed worldwide in the last few years increased significantly, the surgical and anesthetic techniques used for these procedures changed overtime (2). TKA patients experience severe postoperative pain. Failure to suppress that pain interferes with early postoperative patient’s ambulation and rapid rehabilitation, which are important for success of the surgery and rapid hospital discharge (3). In the past, postoperative analgesia following TKA was achieved by either intravenous-patient controlled analgesia (PCA) or epidural analgesia. Each technique has obvious advantages and disadvantages, for example, opioids does not usually provide adequate analgesia and often cause sedation, nausea or vomiting and delayed bowel movement. Epidural analgesia provides superior analgesia but is associated with hypotension, urinary retention and muscle weakness that delay early ambulation (4). Recently, other analgesic techniques like peripheral nerve blockade, commonly used are Femoral nerve block or Adductor canal block and Peri or intra-articular injections have been used successfully with fewer side effects when compared to the conventional analgesic techniques (5). The outcomes of a clinical intervention obtained by the patient i.e. patient-reported outcomes (PROs) seem to be very important in the coming years than any other outcomes. unlike that seen for traditional outcomes of mortality and morbidity, the effect of postoperative analgesia on patient-reported outcomes is dependent on patient’s subjective assessment of multiple outcomes that are not only related to the level of the analgesia provided but also by the presence of any analgesic side effects or complications (6). The presence or absence of side effects and the efficacy of postoperative analgesia are extremely important
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 10/04/2019
Actual trial start date
Anticipated date of last follow up 15/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
Recruitment status 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group periarticular injections 200 mg 0.5% bupivacaine ,5 mg morphine and 200 µg epinephrine 24 hrs All patients randomized to periarticular injections will receive local anesthetic cocktail, consisting of 200 mg 0.5% bupivacaine ,5 mg morphine and 200 µg epinephrine mixed with sterile normal saline solution to ultimately make up a combined volume of 50 ml. A well trained surgeon will perform the local infiltration that will include deep injection prior to cementation and more superficial injection prior to closure of the wound. General anesthesia will be induced for all patients by administration of propofol and fentanyl. All patients will be discharged to their rooms after awaking from anesthesia following fulfillment of discharge criteria. All patients will be prescribed regular acetaminophen and ketorolac at regular intervals for postoperative pain relief. 65
Control Group Femoral nerve block 30 ml of bupivacaine 0.25% with adrenaline 1:200,000 24 hrs On the day of the procedure, all patients will be admitted at the pre-operative holding area all patients will receive the same combination of oral medication :300 mg gabapentin and 1000 mg acetaminophen. All patients randomized to femoral nerve block (FNB)will receive the block guided with ultrasound and nerve stimulator at the discretion of the anesthesiologist and subsequent infiltration of 30 ml of bupivacaine 0.25% with adrenaline 1:200,000 will be administrated. 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
One hundred and thirty patients scheduled for unilateral total knee arthroplasty will be selected with the following inclusion criteria: ASA grade 1-111, able to understand and communicate with the anesthetists and an age between 40-80 years. Exclusion criteria of the patients: previous major knee surgery to the same side, overweight (BMI >35), Rheumatoid arthritis, chronic opioid use (more than 3 months), hepatic or renal failure, allergy to any of the drug used in this study and history of any psychiatric disease that could affect perception of pain or communication with the medical staff. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 04/04/2019 Research ethics committee for human subject research at faculty of medicin Helwan university Cairo Egypt
Ethics Committee Address
Street address City Postal code Country
Al Gamaa, Al Masaken Al Iqtisadeyah Cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome quality of recovery preoperative and 24 hrs after post-operative
Secondary Outcome Pain scores will be assessed by visual analogue scale (VAS). The score ranged from 0-10 that will be evaluated by blinded investigator at 3.6.12,18 and 24 h postoperatively during rest and mobilization.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Andalusia Smouha hospital smouha Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The research is self funded by the researcher dr.tarek ismail 152 TIBA st., Sporting Alexandria 21617 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr tarek ismail sabry mohamed 152 TIBA st. sporting Alexandria 21617 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Mohamed Hossam Elshafie El hadara orthodepic Alexandria university hospital Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tarek ismail sabry mohamed ismail drtarek.anesth@gmail.com 00201001467166 152 tiba st., sporting
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Hanan Mina hananminaped@gmail.com 00201203032096 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of pediatrics Faculty of medicin Helwan university Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Tarek salem tareksalem00@gmail.com 00201112277417 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
cairo Egypt Vice Dean of Graduat Studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes patients data after data entry in excel sheets. Analytic Code,Statistical Analysis Plan,Study Protocol additional documents will be available within 12 months after completion of the study. open access to IPD to reviewers. Data will be send directly by email upon request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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