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

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: 15.1Level: LLTClassification code 10011123Term: Correction Hallux ValgusSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
MedDRA version: 15.1Level: LLTClassification code 10019095Term: Hallux Valgus correctionSystem Organ Class: 100000004865

Registration Number: EUCTR2012-005705-49-BE

Lead Sponsor: zna middelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.