Clinical trial NCT01062919: Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
Official title: Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative functional recovery
timeFrame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: at 24, 48, 72 hours after the surgery
measure: opioid consumption
timeFrame: at 24, 48, 72 hours after the surgery
measure: opioid side effects
timeFrame: at 24, 48, 72 hours after the surgery
measure: return of bowel function
timeFrame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.
measure: length of hospital stay
timeFrame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Healt Centre
name: Franco Carli, Professor
role: PRINCIPAL_INVESTIGATOR
References: