Does a loco-regional block work better if we change the cocktail given using different mixtures of already registrated products.

Conditions: Foot and ankle surgery is associated with postoperative pain. Although single shot sciatic nerve blockade at the popliteal fossa (SSPFB) minimizes the administration of opioids, the duration of analgesia is still limited. This double-blinded, placebo controlled study addressed the question whether or not adding dexamethasone (4mg) or clonidine (100mcg) may prolong the analgesia of a SSPFB with ropivacaine during hallux valgus surgery in comparison to a control group with plain ropivacaine.
MedDRA version: 14.1Level: LLTClassification code 10011123Term: Correction Hallux ValgusSystem Organ Class: 100000004865
MedDRA version: 14.1Level: LLTClassification code 10019095Term: Hallux Valgus correctionSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-005573-31-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 100
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 was time to first pain sensation and achieve a better postoperative pain management. ;Secondary Objective: Secondary endpoints are onset time and total block recovery time.;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 is onset time and total block recovery time.;Timepoint(s) of evaluation of this end point: time to first and complete block regression