Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery
Condition: Postoperative Pain; Surgery; Postoperative Complications
MeSH terms: Pain, Postoperative; Postoperative Complications; Surgical Wound
Intervention: ropivacaine; saline solution
Intervention description: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
Hepatic surgery: 10 ml de ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.; Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
Intervention MeSH terms: Ropivacaine; Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: postoperative pain; wound infusion; local anesthesia

Summary:

      The purpose of this study is to determine whether a continuous infusion of local anesthesia
      with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the
      48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery
      versus the continuous infusion of physiological serum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  Undergoing scheduled colorectal cancer and hepatic surgery

          -  Patients must be able to understand the PCA (the self administration system)

        Exclusion Criteria:

          -  Background of allergic reaction or contraindication for local anesthesia or non
             steroid anti-inflammatory drugs.

          -  Patient with epidural catheter or receiving combined analgesia during surgery (age
             above 80, moderate-severe respiratory dysfunction, patients who prior presented
             complex postoperative pain management.

          -  Emergency surgery

          -  Patients with risk of hepatic insufficiency (Klatskin's tumor, extended right
             hepatectomy, right hepatectomy in patients with steatosis, hepatic resection in
             patients over 70 years of age who have been given chemotherapy).

          -  Inflammatory bowel disease: ulcerative colitis, Crohn's disease.

          -  Major psychiatric condition.

          -  Patients with active drug addiction or on chronic treatment with opiates.

          -  Morbid obesity (BMI > 35 kg/m2)

          -  Patients with heart disease (myocardiopathy, conduction alterations, antiarrhythmic
             treatment) and severe liver disease (alteration synthesis, histolysis and or
             cholestasis).

          -  Patients with kidney failure.

          -  Patients treated with fluvoxamine (antidepressant) and enoxacin (antibiotic) both are
             potent inhibitors of CYPIA2.

          -  Septic patients

          -  Patients that do not wish to participate.