The effects of various concentrations of ropivacaine on the onset and duration of ultrasound-guided ankle blocks in patients undergoing hallux valgus repair surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ziekenhuis Oost Limburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

Trial duration

22 May 2025 → ongoing

Decision date (initial)

2024-04-26

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ziekenhuis Oost-Limburg

External identifiers

EU CT number

2024-510569-41-00

ClinicalTrials.gov

NCT06185608

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacodynamic, Efficacy

To compare the duration of the sensory block in patients having hallux valgus repair surgery under ankle
block with 0.25%, 0.5%, and 1% ropivacaine over a 48-hour period.

Secondary objectives 4

1. To compare the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the onset time of a sensory block in patients having hallux valgus repair surgery under an ankle block over a 30-minute period.
2. To compare the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the motor function in patients having hallux valgus repair surgery under an ankle block over a 48-hour period.
3. To compare the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the postoperative pain scores using a numeric rating scale (NRS) in patients undergoing hallux valgus repair surgery with an ankle block over a 48-hour period.
4. To compare the differential effects of 0.25%, 0.5%, and 1% ropivacaine on postoperative opioid consumption in patients having hallux valgus repair surgery under an ankle block over a 48-hour period.

Conditions and MedDRA coding

Hallux valgus

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Provide signed consent and dated informed consent
2. Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
3. American Society of Anesthesiologists (ASA) physical status I-II-III
4. Able to ambulate (ability to walk independently, without assistive devices)
5. Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick, cold, light touch sensation test) as the patient will have to perform these sensory and motor assessments by themselves at home at postoperative days 0 to 2

Exclusion criteria 8

1. Language barrier
2. Preexisting lower extremity neuropathy
3. Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
4. Contraindications for use of non-steroidal anti-inflammatory drugs (NSAIDs)
5. Allergy to local anesthetics
6. Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
7. Weight below 50 kg (based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine)
8. Preoperative use of opioids or gabapentin less than 3 days before surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the difference in the duration of the sensory blocks.

Secondary endpoints 4

1. The difference in onset time of the sensory block.
2. The difference in motor function.
3. The difference in postoperative pain scores (analgesia).
4. The difference in opioid consumption.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ziekenhuis Oost Limburg

Sponsor organisation

Ziekenhuis Oost Limburg

Address

Synaps Park 1

City

Genk

Postcode

3600

Country

Belgium

Scientific contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Clinical Trial Unit

Public contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Clinical Trial Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications