Continuous Saphenous Nerve Block for Total Knee Arthroplasty

January 18, 2012 updated by: Henning Lykke Andersen

Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Anaestesiafdelingen, Frederiksberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Saline boluses in nerve catheter
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Procedure: Saline boluses in nerve catheter
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
ACTIVE_COMPARATOR: Continuous saphenous nerve block
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Procedure: continuous saphenous nerve block
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 3 days postoperative
VAS pain scores
3 days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Opioid consumption
Time Frame: 3 days postoperative
3 days postoperative
physical therapy progress
Time Frame: 3 days postoperative
3 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henning Lykke Andersen

Investigators

  • Principal Investigator: Henning L. Andersen, M.D., Frederiksberg Hospital
  • Study Director: Dusanka Zaric, M.D., Ph.d., Frederiksberg Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (ESTIMATE)

April 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2010-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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