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

Phase 1

Conditions: Analgesic efficacy in postoperative acute pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-003346-16-ES

Lead Sponsor: Hospital Universitari Sagrat cor

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

- 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

- 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 <50ml/min or creatinine >2mg/dl
- Severe emotional depression, dementia and/or mental disorders
- Obesity: Body mass index >30 Kg/m2
- Refusing to provide informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Adverse events<br>- 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 Outcome Measures