Clinical trial • Not applicable • Other

ROPIVACAINE for Hallux valgus

Not applicable trial of ROPIVACAINE for Hallux valgus.

Overview

Trial Therapeutic Area: Other
Trial Disease: Hallux valgus
Trial Stage: Not applicable
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 22-01-2024
First CTIS Authorization Date: 26-04-2024

Trial design

Randomised, three parallel active comparator arms using different concentrations of the same drug (ropivacaine): 0.25% ropivacaine (15 ml total: 6 ml tibial nerve, 3 ml deep peroneal nerve, 2 ml superficial peroneal nerve, 2 ml saphenous nerve, 2 ml sural nerve); 0.5% ropivacaine (15 ml total with same nerve distribution); 1% ropivacaine (15 ml total with same nerve distribution). no placebo arm specified; patients and outcome assessors blinded while staff performing blocks not blinded.-controlled Not applicable trial across 1 site in Belgium.

Randomised: Yes
Comparator: Three parallel active comparator arms using different concentrations of the same drug (ropivacaine): 0.25% ropivacaine (15 ml total: 6 ml tibial nerve, 3 ml deep peroneal nerve, 2 ml superficial peroneal nerve, 2 ml saphenous nerve, 2 ml sural nerve); 0.5% ropivacaine (15 ml total with same nerve distribution); 1% ropivacaine (15 ml total with same nerve distribution). No placebo arm specified; patients and outcome assessors blinded while staff performing blocks not blinded.
Target Sample Size: 174
Trial Duration For Participant: 2

Eligibility

Recruits 174 Not a vulnerable population. Participants are adults aged 18 to 75. Participants must provide signed and dated informed consent (see inclusion criterion and Subject Information and ICF adults documents). No assent or parental consent procedures are described. Informed consent documents are available (SIS and ICF adults) and synopses are provided in multiple languages (EN, FR, NL, DE)..

Vulnerable Population: Not a vulnerable population. Participants are adults aged 18 to 75. Participants must provide signed and dated informed consent (see inclusion criterion and Subject Information and ICF adults documents). No assent or parental consent procedures are described. Informed consent documents are available (SIS and ICF adults) and synopses are provided in multiple languages (EN, FR, NL, DE).

Inclusion criteria

{"criterion_text":"- Provide signed consent and dated informed consent\n- Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk\n- American Society of Anesthesiologists (ASA) physical status I-II-III\n- Able to ambulate (ability to walk independently, without assistive devices)\n- 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

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

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint is the difference in the duration of the sensory blocks.","definition_or_measurement_approach":"Difference in duration of sensory blocks measured over a 48-hour period following ankle block (as per main objective: compare duration with 0.25%, 0.5%, and 1% ropivacaine over 48 hours)."}

Secondary endpoints

{"endpoint_text":"- The difference in onset time of the sensory block.","definition_or_measurement_approach":"Onset time measured over a 30-minute period post-block (compare onset time between 0.25%, 0.5%, and 1% ropivacaine)."}
{"endpoint_text":"- The difference in motor function.","definition_or_measurement_approach":"Motor function assessed and compared between groups over a 48-hour period following block."}
{"endpoint_text":"- The difference in postoperative pain scores (analgesia).","definition_or_measurement_approach":"Postoperative pain scores measured using a numeric rating scale (NRS) and compared between groups over a 48-hour period."}
{"endpoint_text":"- The difference in opioid consumption.","definition_or_measurement_approach":"Postoperative opioid consumption compared between groups over a 48-hour period."}

Recruitment

Planned Sample Size: 174
Recruitment Window Months: 24
Consent Approach: Informed consent required: participants must provide signed and dated informed consent (inclusion criterion). Subject information and informed consent form documents (SIS and ICF adults) are provided (documents available for publication). Participants are adults (18-75); no assent/parental consent is applicable. Consent materials and protocol synopses are available in multiple languages (EN, FR, NL, DE).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 174

Belgium

Earliest CTIS Part Ii Submission Date: 29-03-2024
Latest Decision Or Authorization Date: 18-03-2026
Processing Time Days: 719
Number Of Sites: 1
Number Of Participants: 174

Sites

Site Name: Ziekenhuis Oost Limburg
Department Name: Anesthesiology
Principal Investigator Name: Imré Van Herreweghe
Principal Investigator Email: imrevanherreweghe@gmail.com
Contact Person Name: Imré Van Herreweghe
Contact Person Email: imrevanherreweghe@gmail.com
Number Of Participants: 174

Sponsor

Primary sponsor

Full Name: Ziekenhuis Oost Limburg
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Belgium

Investigational products

Investigational Product Name: ROPIVACAINE
Active Substance: ROPIVACAINE
Modality: Small molecule
Routes Of Administration: Perineural use (ankle block)
Route: Perineural (ankle block)
Authorisation Status: Authorised
Starting Dose: 15 ml of 0.25% ropivacaine administered perineurally (6 ml tibial, 3 ml deep peroneal, 2 ml superficial peroneal, 2 ml saphenous, 2 ml sural)
Dose Levels: 15 ml of 0.25% ropivacaine | 15 ml of 0.5% ropivacaine | 15 ml of 1% ropivacaine
Frequency: Single administration (single ankle block at surgery)
Maximum Dose: 3 mg/kg (maximum 150 mg)

Related trials

Other published trials that may interest you.