Does a lower concentration of local anesthetic produce a satisfactory postoperative pain management

“Comparison of the onset and duration of postoperative analgesia using a popliteal block with different concentrations of local anesthetics »

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005705-49-BE

Enrollment

Registered

2013-01-07

Start date

2013-01-24

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In our first study we were able to prove that dexamethasone prolongs total block (sensory and motor block) duration as well as time to pain when dexamaethasone is used as an additive to naropin in a popliteal block for hallux valgus repair surgery. In this study we want to prove that we can lower the concentration of local anesthetic in order to lower total dose with less motor block and comparable patient satisfaction. MedDRA version: 15.1 Level: LLT Classification code 10011123 Term: Co

Interventions

Trade Name: naropin Product Name: naropin Pharmaceutical Form: Injection INN or Proposed INN: naropin CAS Number: 132112-35-7 Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are: * physical status ASA I-II (Table 1), age 16-70 years * patient scheduled for elective fore foot surgery (hallux valgus) * scheduled surgery time between 20 and 90 min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria are: • ASA III-IV-V • Chronic renal insufficiency (serum creatinine > 0.45 mg/dl); • Surgery duration of less than 20 minutes and longer than 90 minutes ; • Known coagulation disorders; • Known allergy to local anethetics; • Preoperative use of analgetics/opioids; • (Chronic) pain syndromes; • Psychiatric patients; • Peripheral neuropathy; • Diabetes Mellitus; • Gastric or duodenal ulcers; • Contraindications to loco-regional anesthesia (local or systemic sepsis, operator inexperience and patient or parent refusal) • Plasma haemoglobin concentration below 8 g/dl

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome is time to first pain sensation and the achievement of an equal sensory but lesser motor block.;Secondary Objective: Secondary endpoints are onset time and total block recovery times.;Primary end point(s): The primary outcome is time to first pain sensation.;Timepoint(s) of evaluation of this end point: Time to block duration.	—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are onset times and total block recovery time. ;Timepoint(s) of evaluation of this end point: Time to first and complete block regression.	—

Countries

Belgium

Contacts

Public Contactkris vermeylen

zna middelheim

kris.vermeylen@gmail.com3232803938

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026