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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.

Phase 4
18 Years
80 Years
Open (Enrolling)
Postoperative Pain, Major Abdominal Surgery, Postoperative Outcome

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Trial Information

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.

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Mg of morphine consumption during 48 hours administered by patient controlled analgesia system

Outcome Time Frame:

48 hours

Safety Issue:


Principal Investigator

Antònia Dalmau Llitjós, Physical D

Investigator Role:

Study Director

Investigator Affiliation:

Univeritary Hospital of Bellvitge. IDIBELL


Spain: Ethics Committee

Study ID:




Start Date:

March 2009

Completion Date:

June 2013

Related Keywords:

  • Postoperative Pain
  • Major Abdominal Surgery
  • Postoperative Outcome
  • postoperative pain
  • wound infusion
  • local anesthesia
  • Pain, Postoperative