Defining the Best Approach to Block the Pain After Knee Surgery

NCT ID: NCT00294073

Last Updated: 2007-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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The study aims to compare standard techniques used to control pain after knee surgery. The investigators hypothesize that the fascia iliaca block is faster, safer and as good as or better than the femoral block, with or without a stimulating catheter.

Detailed Description

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60 patients being treated for ACL repair or knee arthroplasties under regional anesthesia will be randomized to three groups: Fascia Iliaca Block (FIB), Femoral Block (FB) with stimulating catheter or FB without stimulating catheter. A catheter will be placed according to each technique, before the surgery. A bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. A continuous infusion will be started for 48 hours. All patients receive a standard analgesia cocktail and rescue medication.

Pain and level of activity, as well as side effects, will be evaluated.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fascia Iliaca Block

Intervention Type PROCEDURE

Femoral Block (with stimulating catheter)

Intervention Type PROCEDURE

Femoral Block (without stimulating catheter)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients coming for ACL or knee prosthesis surgery
* Between 18-80 years old
* Consenting for spinal anesthesia

Exclusion Criteria

* Major neurologic diseases
* Obesity with body mass index (BMI) \> 30
* Infection at the punction sites (back and/or groin)
* Diabetes mellitus for longer than 5 years
* Coagulopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Principal Investigators

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Juan F Asenjo, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal General Hospital

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Juan F Asenjo, MD

Role: CONTACT

514-934-1934 ext. 43261

References

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Morau D, Lopez S, Biboulet P, Bernard N, Amar J, Capdevila X. Comparison of continuous 3-in-1 and fascia Iliaca compartment blocks for postoperative analgesia: feasibility, catheter migration, distribution of sensory block, and analgesic efficacy. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):309-14. doi: 10.1016/s1098-7339(03)00183-4.

Reference Type BACKGROUND
PMID: 12945024 (View on PubMed)

Salinas FV, Neal JM, Sueda LA, Kopacz DJ, Liu SS. Prospective comparison of continuous femoral nerve block with nonstimulating catheter placement versus stimulating catheter-guided perineural placement in volunteers. Reg Anesth Pain Med. 2004 May-Jun;29(3):212-20. doi: 10.1016/j.rapm.2004.02.009.

Reference Type BACKGROUND
PMID: 15138905 (View on PubMed)

Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.

Reference Type BACKGROUND
PMID: 15108988 (View on PubMed)

Eriksson E. Pain relief after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 May;12(3):179. doi: 10.1007/s00167-004-0526-4. Epub 2004 Apr 21. No abstract available.

Reference Type BACKGROUND
PMID: 15103457 (View on PubMed)

Other Identifiers

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REC#02-030

Identifier Type: -

Identifier Source: secondary_id

GEN#05-002

Identifier Type: -

Identifier Source: org_study_id