NCT01077752

Brief Summary

In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

February 26, 2010

Last Update Submit

January 20, 2014

Conditions

Pain, Postoperative

Keywords

Pain, postoperativeLocal infiltrationHyperalgesia, postoperativeLocal anesthetic, ropivacaine, lidocaineColorectal laparoscopic surgeryPain management after colorectal laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Pericicatricial hyperalgesia area

    72 hours after surgery

Secondary Outcomes (2)

  • Pain intensity (rest/mobilization and long-term)

    72 hours, 3 months and 6 months after surgery

  • Morphine consumption

    During 5 days after surgery

Study Arms (3)

1

EXPERIMENTAL

Patients with continuous ropivacaine preperitoneal infusion

Drug: continuous ropivacaine preperitoneal infusionDrug: parenteral analgesia combining acetaminophen and morphine

2

ACTIVE COMPARATOR

Patients with intravenous lidocaine infusion

Drug: intravenous lidocaine infusionDrug: parenteral analgesia combining acetaminophen and morphine

3

PLACEBO COMPARATOR

Patients without local anesthetics

Drug: parenteral analgesia combining acetaminophen and morphineDrug: NaCl

Interventions

continuous ropivacaine preperitoneal infusionDRUG

Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours

1
intravenous lidocaine infusionDRUG

Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours

2
parenteral analgesia combining acetaminophen and morphineDRUG

parenteral analgesia combining acetaminophen and morphine

123
NaClDRUG

NaCl

3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 80
  • ASA status 1 - 3
  • Colorectal laparoscopic surgery with piece removal
  • French speaking
  • Written informed consent

You may not qualify if:

  • laparoscopy without colorectal extraction
  • chronic pain
  • analgesic consumption during the 24 hours previous to the surgery
  • morphine and LA intolerance
  • drug addiction
  • inflammatory bowel disease
  • general inflammatory disease
  • sepsis
  • anemia \< 10 gr/dl
  • liver or renal or cardiac insufficiency
  • uncontrolled diabetes
  • preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
  • preoperative consumption of NSAIDs excluding aspirin referred cardiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain, PostoperativeHyperalgesia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Marc Beaussier, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

February 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

FR(1)