NCT01062919

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

4.3 years

First QC Date

September 22, 2009

Last Update Submit

August 3, 2015

Conditions

Colon CancerInflammatory Bowel DiseasesDiverticulitis

Outcome Measures

Primary Outcomes (1)

  • Postoperative functional recovery

    at 24, 48, 72 hours, 4 and 8 weeks after the surgery

Secondary Outcomes (5)

  • 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.

Study Arms (2)

Epidural analgesia group

EXPERIMENTAL

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.

Procedure: Epidural analgesia

Wound Group

EXPERIMENTAL

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.

Procedure: Wound catheter

Interventions

Epidural analgesiaPROCEDURE

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.

Also known as: Thoracic epidural analgesia
Epidural analgesia group
Wound catheterPROCEDURE

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.

Also known as: Wound catheter continuous infusion
Wound Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective open colon surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3H1A4, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3H1V9, Canada

Location

MeSH Terms

Conditions

Colonic NeoplasmsInflammatory Bowel DiseasesDiverticulitis

Interventions

Analgesia, EpiduralTea

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGastroenteritisDiverticular Diseases

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Franco Carli, Professor

    McGill University Healt Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 22, 2009

First Posted

February 4, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

CA(2)