Clinical trial NCT06112548: The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA
Official title: The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral Total Knee Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Knee
Pain
Arthroplasty Complications
Keywords: total knee arthroplasty
arthritis
pain
injection
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patients with end-stage arthritis of the knee going primary unilateral total knee arthroplasty.

Exclusion Criteria:

* inflammatory and secondary arthritis of the knee.
* Patients who are allergic to one or more of the drugs used in the injections.
* Patients who are already taking opioids for whatever reason or have a history of addiction.
* BMI less than 20 and more than 35.
* patients with intra-operative complications that would affect the outcomes measurement.
* Patients who are going through complex primary or revision TKA.
* Pregnancy, renal or liver failure.
* Patients who are classified as grade 3 or more according to ASA.

Primary outcomes:
measure: perception of pain - first assessment
timeFrame: measured 12 hours after surgery.
measure: perception of pain - second assessment
timeFrame: measured 24 hours after surgery.
measure: perception of pain - third assessment
timeFrame: measured 48 hours after surgery.
measure: functional status - first assessment
timeFrame: first measurement four weeks after surgery.
measure: magnitude of disabling pain according to KSS - first assessment
timeFrame: first measurement four weeks after surgery.
measure: magnitude of disabling pain according to KSS - second assessment
timeFrame: first measurement six months after surgery.
measure: functional status - second assessment
timeFrame: second measurement six months after surgery.
measure: estimated total blood loss
timeFrame: measured once 48 hours after surgery.
Secondary outcomes:
measure: perioperative complications
timeFrame: if happened within 6 months of surgery
measure: opioids consumption - frequency
timeFrame: measured once 48 hours after surgery.
measure: opioids consumption - dose
timeFrame: measured once 48 hours after surgery.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus university
Study officials:
affiliation: Damascus university - faculty of medicine - department of surgery
name: jaber ibrahim, MD PHD
role: STUDY_CHAIR
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