Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty

NCT05324995 | Completed Phase 2

• 1 other identifier: 394048
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib orally (control group) (n=49) using Random Allocation software. The injections and oral therapy were performed within 15 minutes before the surgical procedure. The study's primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.

Conditions

Postoperative Pain; Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Pain; Multimodal analgesia; Range of motion

Outcome Measures

Primary Outcomes (7)

• Baseline Measurements of Knee Society Score (KSS)

  The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.

  At the beginning of the study

• Baseline range of motion (ROM)

  Knee ROM was evaluated using a standard goniometer

  At the beginning of the study

• visual analogue scale (VAS)

  Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale

  24 hours after the surgical procedure

• Range of motion (ROM)

  Knee ROM was evaluated using a standard goniometer

  6 months after surgery

• Knee Society Score (KSS)

  The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.

  6 months after surgery

• visual analogue scale (VAS)

  Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale

  48 hours after the surgical procedure

• visual analogue scale (VAS)

  Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale

  Six weeks after surgery

Study Arms (3)

Multimodal injection

EXPERIMENTAL

The first group was treated using a preemptive periarticular injection of multimodal drugs. Therefore, a combination of drugs consisted of 50 mg bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France), 1 ml morphine sulfate 10 mg/ml (DarouPakhsh, Tehran, Iran), 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) and 30 mg ketorolac (Caspian Tamin, Rasht, Iran) diluted by 0.9% sodium chloride solution to make a total 100 ml of injection drug was injected in periarticular area. The injections were done within 15 minutes before the incision in seven areas of the joint as followed: 15 ml in posterolateral soft tissue and lateral femoral periosteum, 15 ml posteromedial soft tissue and medial femoral periosteum, 20 ml inferomedial capsule, 20 ml superomedial capsule, 10 ml lateral capsule, 10 ml medial subcutaneous tissues and 10 ml lateral subcutaneous tissue.

Drug: Multimodal Drug

epinephrine group (placebo group)

EXPERIMENTAL

The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary, similar to the first group.

Drug: epinephrine

celecoxib group (control group)

EXPERIMENTAL

The third group administered celecoxib (200 mg) orally immediately before the surgery initiation.

Drug: celecoxib

Interventions

Multimodal Drug DRUG

The Multimodal Drug group received morphine, epinephrine, and ketorolac (n=48), The epinephrine group (placebo group) (n=49) received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary,and the celecoxib group(control group)(n=49) recieved 400mg celecoxib orally

Also known as: Case

Multimodal injection

epinephrine DRUG

The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary

Also known as: Placebo

epinephrine group (placebo group)

celecoxib DRUG

The third group administered celecoxib (200 mg) orally immediately before the surgery

Also known as: Control

celecoxib group (control group)

Eligibility Criteria

• Age: 37 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of osteoarthritis
• Candidate for primary unilateral TKA
• Body mass index of 20-30 kg/m2

You may not qualify if:

• Unable to follow-up the assessments
• Having more than 20% defects in medical records

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Epinephrine; Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzenesulfonamides; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator who performed the baseline and follow-up assessments and the patients were unaware of the study group; as the investigator was absent at the time of the surgery and all the patients administered a pill prior to the surgical procedure
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Isfahan University of Medical Sciences

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: April 13, 2022
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After getting the code
• Access Criteria: No limitation

Locations

IR (1)