Randomised and Double-blind Clinical Trial on Post-operative Analgesic Efficacy in Colorectal Surgery and Hepatic Surgery With Continuous Infusion of Local Anesthesia vs Saline Serum in the Surgical Incision.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System
Study Overview
Brief 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.
Detailed Description
Postoperative analgesia in major abdominal surgery is managed with intravenous PCA (patient controlled analgesia) with morphine associated to non-steroidal anti-inflammatories drugs (NSAD) and paracetamol in the first 48 hours of the postoperative phase. With this multimodal approach patients undergoing colorectal surgery have a median pain score on the verbal scale (0-10) of 3 (range 0-8) with a mean of morphine consumption of 54 mg (SD 24 mg) and patients undergoing hepatic surgery have a median pain score of 2(range 0-7) with a mean of morphine consumption of 28 mg (SD 17 mg).
Although opiates are very potent analgesics they also produce side effects and numerous studies have demonstrated a significant reduction in morbidity when patients received lower dose of opiates during anesthesia and in postoperative period. Continuous infusion of local anesthetics in the surgical wound has been used for pain control in different types of surgeries. However, controversial reports has been reported in abdominal surgery.
We are conducting prospective, randomised and double-blind placebo control trials in two surgical models (colo-rectal oncologic surgery and hepatic resection) using continuous perfusion of ropivacaine 0.38% in the surgical wound versus saline.
Anesthetic protocol is the same for all patients.
Patients undergoing colo-rectal surgery can be operated either in laparotomy or laparoscopic technique therefore patients are stratified into four groups once surgical closure has begun:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 CYPIA
- •Septic patients
- •Patients that do not wish to participate.
Arms & Interventions
Ropivacaine
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
Intervention: ropivacaine (Drug)
saline solution
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
Intervention: saline solution (Drug)
Outcomes
Primary Outcomes
Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System
Time Frame: 48 hours
Secondary Outcomes
- Intensity of Pain Measured by Verbal Pain Scale.(At interval periods during 48 hours)
- Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.(7 Days (from Day 8-15))
- Secondary Effects Due to Morphine: Nausea and Vomiting(during 48 hours)
- Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)(During 8-15 days)
- Contamination of the Catheter (Microbiologist Analysis)(at 48 hours)
Investigators
antonia dalmau llitjos
MD PhD
Hospital Universitari de Bellvitge