Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Conditions
Colon Cancer
Intervention
Epidural analgesia, Wound catheter
Location
Montreal General Hospital
Montreal
Quebec
Canada
H3H1A4
Status
Recruiting
Source
McGill University Health Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01062919
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Analgesia, Epidural
The relief of pain without loss of consciousness through the introduction of an analgesic agent into the epidural space of the vertebral canal. It is differentiated from ANESTHESIA, EPIDURAL which refers to the state of insensitivity to sensation.
Epidural Abscess
Circumscribed collections of suppurative material occurring in the spinal or intracranial EPIDURAL SPACE. The majority of epidural abscesses occur in the spinal canal and are associated with OSTEOMYELITIS of a vertebral body; ANALGESIA, EPIDURAL; and other conditions. Clinical manifestations include local and radicular pain, weakness, sensory loss, URINARY INCONTINENCE, and FECAL INCONTINENCE. Cranial epidural abscesses are usually associated with OSTEOMYELITIS of a cranial bone, SINUSITIS, or OTITIS MEDIA. (From Adams et al., Principles of Neurology, 6th ed, p710 and pp1240-1; J Neurol Neurosurg Psychiatry 1998 Aug;65(2):209-12)
Infusions, Intra-arterial
Regional infusion of drugs via an arterial catheter. Often a pump is used to impel the drug through the catheter. Used in therapy of cancer, upper gastrointestinal hemorrhage, infection, and peripheral vascular disease.
Colon
The segment of LARGE INTESTINE between the CECUM and the RECTUM. It includes the ASCENDING COLON; the TRANSVERSE COLON; the DESCENDING COLON; and the SIGMOID COLON.
Blood Patch, Epidural
The injection of autologous blood into the epidural space either as a prophylactic treatment immediately following an epidural puncture or for treatment of headache as a result of an epidural puncture.
Clinical Trials
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PubMed Articles
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