Study of the analgesic efficacy of the intravenous administration of split dosis compared to continuous perfusion in the treatment of postoperative pain.

Comparative study between continuous perfusion and split doses in the treatment of postoperative pain - Elastomeric pumps versus intravenous split doses in postoperative pain

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003346-16-ES

Enrollment

Unknown

Registered

2015-12-10

Start date

2017-02-16

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Analgesic efficacy in postoperative acute pain

Interventions

Trade Name: Metamizol Normon 2 g / 5 ml Solución inyectable EFG Pharmaceutical Form: INN or Proposed INN: METAMIZOLE CAS Number: 50567-35-6 Current Sponsor code: 63.430 Other descriptive name: Dipiro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Over 18 years old - Patients with analgesic needs superior to 48 hours and an equivalent minimal in-hospital stay. - Patients undergoing: . Orthopaedic Surgery: hip prosthesis, shoulder pathologies . General Surgery: eventroplasty, anal fissure and cholectomy . Gynecologic Surgery: hysterectomy - Patients providing informed consent 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) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

Exclusion criteria: - Non elective surgery - Different analgesic requirements - Patient admission to ICU - Allergy or hypersensitivity to any drug used in the study - Contraindication for any of the study drugs: . Medical history of agranulocytosis and aplastic anemia . Acute intermittent porphyria . Glucose 6 phosphate dehydrogenase deficiency . Digestive haemorrhage, esophageal haemorrhage, active peptic ulcer, cranial haemorrhage. . Respiratory depression . Severe chronic obstructive pulmonary disease - Pregnancy suspicion - Failure or severe hepatic insufficiency: score: Child-Pugh 10-15 - Failure or mild-severe renal insufficiency: CICr 2mg/dl - Severe emotional depression, dementia and/or mental disorders - Obesity: Body mass index >30 Kg/m2 - Refusing to provide informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim is to compare the analgesic efficacy between two different administration techniques: elastomeric pump continous perfusion versus intravenous split doses of the same analgesics in surgical patients with a prognosis of mild-severe postoperative pain.;Secondary Objective: To assess, in both analgesic techniques: - Adverse events - Patient confort;Primary end point(s): The administration of analgesia through elastomeric continous perfusion pump provides a best postoperative pain relief and major confort and consequently, major patients satisfaction. A reduction of 50% VAS > 3.;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: The aim is to compare the analgesic efficacy between two different administration techniques: elastomeric pump continous perfusion versus intravenous split doses of the same analgesics in surgical patients with a prognosis of mild-severe postoperative pain.;Secondary Objective: To assess, in both analgesic techniques: - Adverse events - Patient confort;Primary end point(s): The administration of analgesia through elastomeric continous perfusion pump provides a best postoperative pain relief and major confort and consequently, major patients satisfaction. A reduction of 50% VAS > 3.;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): To assess possible adverse events due to analgesic drugs;Timepoint(s) of evaluation of this end point: 48-60 hours	—

Countries

Spain

Contacts

Public ContactBiblioteca

Hospital Universitari Sagrat Cor

bibhsc@hscor.com

Outcome results

None listed

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