Overview
Sponsor-declared trial summary
Postoperative pain after Total Knee Arthroplasty
The aim of this study is to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of local anesthetic as an adjunct to Femoral Triangle Block in a multimodal analgesic regimen following primary unilateral total knee arthroplasty. We hypothesize that using 20 mL of local anesthetic for PPB …
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 30 Mar 2025 → 26 Nov 2025
- Decision date (initial)
- 2025-03-17
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Central Denmark Region · Elective Surgery Centre, Silkeborg Regional Hospital · Aarhus University
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy
The aim of this study is to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of local anesthetic as an adjunct to Femoral Triangle Block in a multimodal analgesic regimen following primary unilateral total knee arthroplasty. We hypothesize that using 20 mL of local anesthetic for PPB instead of 10 mL will decrease 24-hour postoperative opioid consumption.
Conditions and MedDRA coding
Postoperative pain after Total Knee Arthroplasty
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10002325 | Anesthesia local | 10042613 |
| 21.1 | LLT | 10036236 | Postoperative pain relief | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age > 18 years
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia.
- Ability to give their written informed consent after having fully understood the contents of the study.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Exclusion criteria 8
- Patients who cannot read or speak Danish.
- Patients who cannot operate or have access to a smartphone with internet connectivity (required for patient-reported outcome assessment).
- Patients with allergies or intolerance to the medicines used in the study.
- Patients with a consistent daily intake of opioids preoperatively.
- Patients who are dependent on walking aid devices preoperatively.
- Patients suffering from alcohol and/or drug abuse – based on the investigator's assessment.
- BMI > 40.
- Diagnosed with chronic neurodegenerative disorders.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).
Secondary endpoints 6
- Frequency of patients with no opioid consumption from T0 until T24.
- Pain in the operated knee at rest, scored by NRS, obtained at the timepoints: Preoperative, at 6 hours (+/- 1 hour) after end-of-surgery time (T6), and at T24.
- Pain in the operated knee during a 10-meter walk with crutches, scored by NRS, obtained at the time points: Preoperative, T6 and at T24.
- Frequency of patients unable to walk 10 meters with crutches at T6.
- Frequency of Manual Muscle Test results < Grade 3 in evaluations of dorsiflexion and plantarflexion of the ankle and knee extension, examined at T6.
- Patient reported outcome measure of Quality of Recovery 15 at T24.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP131295 · ATC
- Active substance
- Bupivacaine Hydrochloride
- Route of administration
- PERINEURAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Falkevej 1/3
- City
- Silkeborg
- Postcode
- 8600
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Johan Kløvgaard Sørensen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Johan Kløvgaard Sørensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-03-30 | 2025-11-26 | 2025-03-30 | 2025-11-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-132873
|
2026-05-07T15:30:05 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results | 2026-05-07T15:30:58 | Submitted | Laypersons Summary of Results |
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Person Summary of Results | 1 |
| Protocol (for publication) | Protocol_PPB_10vs20_TKA | 2 |
| Recruitment arrangements (for publication) | Informed Consent Patient Recruitment Procedure | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bupivacaine Solution for Injection | 1 |
| Summary of results (for publication) | Summary of Results | 1 |
| Synopsis of the protocol (for publication) | Protokolresume_PPB_10vs20_TKA | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-15 | Denmark | Acceptable 2025-03-17
|
2025-03-17 |