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

Effects of the combination of dexamethasone or clonidine with ropivacaine during a popliteal block : a prospective double blind randomized trial. - POP 1 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005573-31-BE

Enrollment

100

Registered

2013-01-07

Start date

2013-02-07

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

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. Med

Interventions

Trade Name: aacedixam Product Name: aacedixam Pharmaceutical Form: Injection INN or Proposed INN: Aacidexam Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Concentration unit: mg milligram(s) C

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 100 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 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

Measure	Time frame
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	—

Countries

Belgium

Contacts

Public Contactkris vermeylen

zna middelheim

3232803938

Outcome results

None listed

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