Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01062919

Enrollment

Registered

2010-02-04

Start date

2009-07-31

Completion date

2013-10-31

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Diverticulitis, Inflammatory Bowel Diseases

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.

Interventions

PROCEDUREEpidural analgesia

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.

PROCEDUREWound catheter

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Postoperative functional recovery	at 24, 48, 72 hours, 4 and 8 weeks after the surgery

Secondary

Measure	Time frame
postoperative pain	at 24, 48, 72 hours after the surgery
opioid consumption	at 24, 48, 72 hours after the surgery
opioid side effects	at 24, 48, 72 hours after the surgery
return of bowel function	at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.
length of hospital stay	at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026