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Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery (CATROP-2007)

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ClinicalTrials.gov Identifier: NCT01075646
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : November 18, 2016
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Surgery Postoperative Complications Drug: ropivacaine Drug: saline solution Phase 4

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:

  • Group A1 ropivacaine and laparotomy
  • Group A2 ropivacaine and laparoscopy
  • Group B1 saline and laparotomy
  • Group B2 saline and laparoscopy

In the preanesthesia visit patients who match inclusion criteria are invited to participate in the study and they signed the informed consent. When the patient is in the theatre a nurse not involved in the management of patients opens a closed envelope which indicates the solution to be prepared according to the assigned group.

The surgeon inserts a multiperforated catheter at the subfascial level of surgical wound , just below the suture of the muscular fascia (between the peritoneum and the muscular fascia) and after that surgeons finish the subcutaneous plane and the skin. After the closure a bolus of 5 ml (laparoscopy colon surgery)or 10 ml (laparotomy colon and hepatic surgery) of the solution is given through the catheter and subsequently an elastomer filled with ropivacaine or saline is connected. The catheter is fixed to the skin with steri-strip and sterile dressing.

During the procedure we administer in a protocol basis the NSAD and thirty minutes before the end of the surgery we administer morphine. In the postoperative period the patient receives a NSAD regime and a PCA morphine treatment.

The catheter is withdrawn after 48 hours and also the PCA and the analgesic treatment is with NSAD.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2009
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ropivacaine
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
Drug: ropivacaine

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.

Other Name: (wound infusion ropivacaine)
Placebo Comparator: saline solution
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
Drug: saline solution

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

Other Name: wound infusion saline solution

Outcome Measures

Primary Outcome Measures :
  1. Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Intensity of Pain Measured by Verbal Pain Scale. [ Time Frame: At interval periods during 48 hours ]
    Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.

  2. Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. [ Time Frame: 7 Days (from Day 8-15) ]
  3. Secondary Effects Due to Morphine: Nausea and Vomiting [ Time Frame: during 48 hours ]
  4. Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) [ Time Frame: During 8-15 days ]
  5. Contamination of the Catheter (Microbiologist Analysis) [ Time Frame: at 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075646

Anesthesiology Service of Univeritary Hospital of Bellvitge
Hospitalet . Barcelona, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Study Director: Antònia Dalmau Llitjós, Physical D Univeritary Hospital of Bellvitge. IDIBELL
More Information


Responsible Party: antonia dalmau llitjos, MD PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01075646     History of Changes
First Posted: February 25, 2010    Key Record Dates
Results First Posted: November 18, 2016
Last Update Posted: March 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by antonia dalmau llitjos, Hospital Universitari de Bellvitge:
postoperative pain
wound infusion
local anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Surgical Wound
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Wounds and Injuries
Pharmaceutical Solutions
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents