Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Franco Carli

Status: Terminated

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Treatments: Procedure: Wound catheter; Procedure: Epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01062919

GEN-08-070

Details and patient eligibility

About

This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.

Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).

Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.

Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.

Full description

This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective open colon surgery

Exclusion criteria

• ASA physical status 4

• history of:

  • hepatic failure (liver enzymes abnormally elevated)
  • renal failure (creatinine over 150 mmol/L)
  • cardiac failure
  • organ transplant
  • diabetes
  • morbid obesity (BMI > 40 kg/m-2)
  • chronic use of opioids
  • allergy to local anaesthetics

• History of seizure

• contraindications to the insertion of epidural

• INR > 1.3, PTT > 44 second, platelets < 150.000 per microliter,

• previous spinal surgery limiting the insertion)

• inability to comprehend pain assessment

Trial design

10 participants in 2 patient groups

Epidural analgesia group

Experimental group

Description:

patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.

Treatment:

Procedure: Epidural analgesia

Wound Group

Experimental group

Description:

patients in the epidural analgesia group will receive ropivacaine 0.2% through the wound catheter, normal saline in the epidural catheter and PCA with morphine.

Treatment:

Procedure: Wound catheter