This interventional study aims to compare the effectiveness of local multimodal drug periarticular injection in TKA patients with the standard pain control regime that includes opioids, NSAIDs, and other analgesics. The main questions The investigators strive to answer are: Is there a significant difference in the severity of pain and functional outcomes when applying periarticular injections? Are there any increased complications when applying the periarticular injections?
The best pain control regime following TKA is controversial. While opioids have an excellent analgesic effect, they also have many side effects. The investigators are conducting a randomized controlled trial to compare the severity of pain following primary unilateral TKA when multimodal drug periarticular injunction is used with the standard pain control regime. The investigators will enroll patients undergoing primary unilateral TKA and randomly allocate them into one treatment group. The first will undergo the procedure with periarticular injection before the closure is composed of a mixture of 20ml of low body weight bupivacaine 5mg/ml plus 1ml of ketorolac 30mg/ml plus 0.5ml adrenaline 1mg/ml injected in medial and lateral retinaculum, medial and lateral collateral ligaments, quadriceps and patellar tendon, joint capsule, subcutaneous fat, and the second will go standard TKA with pain control using opioids, NSAIDS, and paracetamol. The severity of postoperative pain is the primary outcome studied, as well as preoperative complications and any drug side effects, the data will be collected by a fellow researcher who is blinded to the interventions, and the patients will be blinded too. Randomization will be done by a research fellow who is not involved in patient treatment or care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.
low body weight (0.50%, 20cc) intraoperative periarticular injection
1ml of 30mg/ml ketorolac intraoperative periarticular injection
0.5ml Adrenaline 1mg/ml intraoperative periarticular injection
IV Paracetamol \[Ofirmev\] introduced every 6 hours after surgery
IV Ketorolac {Toradol} introduced every 12 hours after surgery.
IV Tramadol \[Ultram\] introduced when needed after surgery
Damascus university
Damascus, Syria
RECRUITINGperception of pain - first assessment
The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine.
Time frame: measured 12 hours after surgery.
perception of pain - second assessment
The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine.
Time frame: measured 24 hours after surgery.
perception of pain - third assessment
The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine.
Time frame: measured 48 hours after surgery.
functional status - first assessment
a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. here, the investigator assesses the function section.
Time frame: first measurement four weeks after surgery.
magnitude of disabling pain according to KSS - first assessment
a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100, with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. Here the investigator assesses the pain section.
Time frame: first measurement four weeks after surgery.
magnitude of disabling pain according to KSS - second assessment
a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100, with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. Here the investigator assesses the pain section.
Time frame: first measurement six months after surgery.
functional status - second assessment
a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. here, the investigator assesses the function section.
Time frame: second measurement six months after surgery.
estimated total blood loss
the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
Time frame: measured once 48 hours after surgery.
perioperative complications
complications such as Venous thromboembolism VTE, infection, drug side effects ETC
Time frame: if happened within 6 months of surgery
opioids consumption - frequency
the amount of consumed opioids measured by times of application in the close postoperative period
Time frame: measured once 48 hours after surgery.
opioids consumption - dose
the amount of consumed opioids measured by the dose used in the close postoperative period
Time frame: measured once 48 hours after surgery.
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