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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospital Universitari de Bellvitge
Sponsor:
Information provided by (Responsible Party):
antonia dalmau llitjos, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01075646
First received: January 11, 2010
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Postoperative Pain
Major Abdominal Surgery
Postoperative Outcome
Drug: ropivacaine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Mg of morphine consumption during 48 hours administered by patient controlled analgesia system [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of pain measured by verbal pain scale. [ Time Frame: At interval periods during 48 hours ] [ Designated as safety issue: No ]
  • Sitting in a chair, Deambulation, solid ingestion. [ Time Frame: 8-15 days ] [ Designated as safety issue: No ]
  • secondary effects due to morphine: nausea and vomiting, itching, sedation and respiratory depression. [ Time Frame: during 48 hours ] [ Designated as safety issue: Yes ]
  • Local reaction in the wound and insertion point of the catheter (inflammation signs and infection) [ Time Frame: During 8-15 days ] [ Designated as safety issue: Yes ]
  • contamination of the catheter (microbiologist analysis) [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: placebo

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075646

Contacts
Contact: Antonia Dalmau Llitjós, PhD, MD 0034 932607323 madalmau@bellvitgehospital.cat
Contact: Noelia Fustran Guerrero, MD 0034 932607323 nfustran@bellvitgehospital.cat

Locations
Spain
Anesthesiology Service of Univeritary Hospital of Bellvitge Recruiting
Hospitalet . Barcelona, Barcelona, Spain, 08907
Contact: Antonia Dalmau LLitjos, MD PhD    +34 93 260 7323    madalmau@bellvitgehospital.cat   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Study Director: Antònia Dalmau Llitjós, Physical D Univeritary Hospital of Bellvitge. IDIBELL
  More Information

Publications:

Responsible Party: antonia dalmau llitjos, MD PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01075646     History of Changes
Other Study ID Numbers: ANESTHESIA SERVICE HUB
Study First Received: January 11, 2010
Last Updated: December 27, 2013
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
postoperative pain
wound infusion
local anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014