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Comparative study of three types of anesthesia on postoperative pain after colon surgery

Conditions
Postoperative pain
MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2013-000556-17-ES
Lead Sponsor
Fundació Parc Taulí
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

age 18 years, informed consent of the study, patients without contraindication for performance of any of the three analgesic techniques.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

emergency surgery, impaired higher functions, ASA IV patients, chronic treatment with opioids.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Primary objective: To determine the effectiveness of three analgesic techniques used in the control of postoperative pain after laparoscopic sigmoidectomy and determine which one offers a lower incidence of adverse effects.;Secondary Objective: Secondary objective: To compare time from surgery until discharge depending on the type of analgesia used.; Compare the total economic cost in terms of the drugs administered, staff involved and hospital stay.;Primary end point(s): Primary endpoint: pain control in the first 48 hours postoperatively;Timepoint(s) of evaluation of this end point: First 48 hours postoperatively
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Secondary variables: presence of ileus, lower extremity paresthesias, nausea or vomiting, acute urinary retention, respiratory depression, hypotension. Economic costs.;Timepoint(s) of evaluation of this end point: Up to patient discharge
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