the Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA

Sponsor

Damascus University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112548

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Pain Arthroplasty Complications	Procedure: primary unilateral TKA Drug: Bupivacain Drug: ketorolac Drug: epinephrine Drug: Paracetamol Drug: Ketorolac Drug: Tramadol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral Total Knee Arthroplasty: a Randomized Controlled Trial

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TKA with pain management by multimodal periarticular injection. Patients going TKA and getting an injection 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 before closure.	Procedure: primary unilateral TKA Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis. Drug: Bupivacain low body weight (0.50%, 20cc) intraoperative periarticular injection Drug: ketorolac 1ml of 30mg/ml ketorolac intraoperative periarticular injection Other Names: Toradol Drug: epinephrine 0.5ml Adrenaline 1mg/ml intraoperative periarticular injection Other Names: Adrenaline Drug: Tramadol IV Tramadol [Ultram] introduced when needed after surgery
Experimental: TKA with pain management by IV/oral analgesics. Patients going TKA and getting a standard pain control regime of IV opioids when needed, IV ketorolac, and IV/oral paracetamol.	Procedure: primary unilateral TKA Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis. Drug: Paracetamol IV Paracetamol [Ofirmev] introduced every 6 hours after surgery Drug: Ketorolac IV Ketorolac {Toradol} introduced every 12 hours after surgery. Drug: Tramadol IV Tramadol [Ultram] introduced when needed after surgery

Arm

Intervention/Treatment

Experimental: TKA with pain management by multimodal periarticular injection.

Patients going TKA and getting an injection 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 before closure.

Procedure: primary unilateral TKA

Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.

Drug: Bupivacain

low body weight (0.50%, 20cc) intraoperative periarticular injection

Drug: ketorolac

1ml of 30mg/ml ketorolac intraoperative periarticular injection

Other Names:

Toradol

Drug: epinephrine

0.5ml Adrenaline 1mg/ml intraoperative periarticular injection

Other Names:

Adrenaline

Drug: Tramadol

IV Tramadol [Ultram] introduced when needed after surgery

Experimental: TKA with pain management by IV/oral analgesics.

Patients going TKA and getting a standard pain control regime of IV opioids when needed, IV ketorolac, and IV/oral paracetamol.

Procedure: primary unilateral TKA

Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.

Drug: Paracetamol

IV Paracetamol [Ofirmev] introduced every 6 hours after surgery

Drug: Ketorolac

IV Ketorolac {Toradol} introduced every 12 hours after surgery.

Drug: Tramadol

IV Tramadol [Ultram] introduced when needed after surgery

Outcome Measures

Primary Outcome Measures

perception of pain - first assessment [measured 12 hours after surgery.]
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.
perception of pain - second assessment [measured 24 hours after surgery.]
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.
perception of pain - third assessment [measured 48 hours after surgery.]
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.
functional status - first assessment [first measurement four weeks after surgery.]
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.
magnitude of disabling pain according to KSS - first assessment [first measurement four weeks after surgery.]
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.
magnitude of disabling pain according to KSS - second assessment [first measurement six months after surgery.]
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.
functional status - second assessment [second measurement six months after surgery.]
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.
estimated total blood loss [measured once 48 hours after surgery.]
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

Secondary Outcome Measures

perioperative complications [if happened within 6 months of surgery]
complications such as Venous thromboembolism VTE, infection, drug side effects ETC
opioids consumption - frequency [measured once 48 hours after surgery.]
the amount of consumed opioids measured by times of application in the close postoperative period
opioids consumption - dose [measured once 48 hours after surgery.]
the amount of consumed opioids measured by the dose used in the close postoperative period

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.