Continuous Saphenous Nerve Block for Total Knee Arthroplasty

NCT ID: NCT01332045

Last Updated: 2012-01-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.

The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.

If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.

Detailed Description

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline boluses in nerve catheter

A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.

Group Type SHAM_COMPARATOR

Saline boluses in nerve catheter

Intervention Type PROCEDURE

A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.

Continuous saphenous nerve block

Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days

Group Type ACTIVE_COMPARATOR

continuous saphenous nerve block

Intervention Type PROCEDURE

Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days

Interventions

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continuous saphenous nerve block

Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days

Intervention Type PROCEDURE

Saline boluses in nerve catheter

A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* Age: 40-75
* Unilateral TKA
* Use of Spinal anesthesia

Exclusion Criteria

* Allergy to any of the study medications
* Intolerance to morphine
* Contraindication to a spinal anesthetic
* Intraoperative use of any volatile anesthetic
* Chronic opioid use
* ASA Class 4-5
* Rheumatoid arthritis or Diabetes mellitus with neuropathy
* Liver or kidney failure
* BMI above 40
* Severe COPD
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henning Lykke Andersen

OTHER

Sponsor Role lead

Responsible Party

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Henning Lykke Andersen

Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henning L. Andersen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Frederiksberg Hospital

Dusanka Zaric, M.D., Ph.d.

Role: STUDY_DIRECTOR

Frederiksberg Hospital.

Locations

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Anaestesiafdelingen, Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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Andersen HL, Gyrn J, Moller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9.

Reference Type DERIVED
PMID: 23222363 (View on PubMed)

Related Links

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Other Identifiers

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H-3-2010-124

Identifier Type: -

Identifier Source: org_study_id

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