Phase 4
Completed N=166
Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery
Postoperative Pain · Surgery · Postoperative Complications
Source: ClinicalTrials.gov NCT01075646 ↗
Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System — 23; 52; 24.63; 26.78 mg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System |
23; 52; 24.63; 26.78 | — |
| SECONDARY Intensity of Pain Measured by Verbal Pain Scale. |
1; 2.5; 2.75; 2.5; 2; 3 | — |
| SECONDARY Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. |
46; 48; 51.75; 43.2; 72; 72 | — |
| SECONDARY Secondary Effects Due to Morphine: Nausea and Vomiting |
5; 6; 2; 6; 28; 28 | — |
| SECONDARY Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) |
6; 10; 2; 2; 27; 24 | — |
| SECONDARY Contamination of the Catheter (Microbiologist Analysis) |
6; 4; 2; 2; 27; 30 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01075646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.