---
title: Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
nct_id: NCT00901628
overall_status: COMPLETED
phase: PHASE4
sponsor: Seoul National University Hospital
study_type: INTERVENTIONAL
primary_condition: Osteoarthritis, Knee
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00901628.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00901628"
ct_last_update_post_date: 2013-01-25
last_seen_at: "2026-05-12T07:17:51.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

**Official Title:** Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

**NCT ID:** [NCT00901628](https://clinicaltrials.gov/study/NCT00901628)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 101
- **Lead Sponsor:** Seoul National University Hospital
- **Conditions:** Osteoarthritis, Knee
- **Start Date:** 2008-04
- **Completion Date:** 2009-04
- **CT.gov Last Update:** 2013-01-25

## Brief Summary

The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

## Detailed Description

The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 81 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Diagnosis of primary osteoarthritis
* Scheduled for elective total knee arthroplasty
* Signed written informed consent
* Spinal anesthesia

Exclusion Criteria:

* Patients refusing consents
* inability to use the outcome assessment tools
* Contraindications to regional anesthesia
* severe cardiovascular disease
* allergy or contraindication to drugs used in this study
* pre-existing neurologic disease including psychiatric disorder
* drug abuser
```

## Arms

- **Periarticular Injection group** (EXPERIMENTAL) — Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
- **No Injection group** (NO_INTERVENTION) — usual postoperative care without periarticular injection

## Interventions

- **ropivacaine** (DRUG) — 300mg (0.75%, 40cc) intraoperative periarticular injection
- **morphine sulfate** (DRUG) — 10mg intraoperative periarticular injection
- **ketorolac** (DRUG) — 30 mg intraoperative periarticular injection
- **epinephrine** (DRUG) — 300 microgram (1:1000) intraoperative periarticular injection
- **cefuroxime** (DRUG) — 750mg intraoperative periarticular injection

## Primary Outcomes

- **Pain( Visual Analog Scale )** _(time frame: the night after surgery)_ — An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.

## Secondary Outcomes

- **Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery** _(time frame: 24 hours postoperative)_
- **Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery** _(time frame: 24 hours after surgery)_
- **the Proportion of Patients Who Were Satisfied With the Pain Management** _(time frame: postoperative 7 day)_
- **The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended** _(time frame: 24 hours postoperative)_
- **Maximal Flexion Angle Degree on Postoperative 7 Day** _(time frame: postoperative 7 day)_

## Locations (1)

- Joint Reconstruction Center, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.joint reconstruction center, seoul national university bundang hospital|seongnam-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

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