NCT01332045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

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

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

April 7, 2011

Last Update Submit

January 18, 2012

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    VAS pain scores

    3 days postoperative

Secondary Outcomes (2)

  • Opioid consumption

    3 days postoperative

  • physical therapy progress

    3 days postoperative

Study Arms (2)

Saline boluses in nerve catheter

SHAM COMPARATOR

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

Procedure: Saline boluses in nerve catheter

Continuous saphenous nerve block

ACTIVE COMPARATOR

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

Procedure: continuous saphenous nerve block

Interventions

continuous saphenous nerve blockPROCEDURE

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

Continuous saphenous nerve block
Saline boluses in nerve catheterPROCEDURE

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

Saline boluses in nerve catheter

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaestesiafdelingen, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23222363DERIVED

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Henning L. Andersen, M.D.

    Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

  • Dusanka Zaric, M.D., Ph.d.

    Frederiksberg Hospital.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 8, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

DK(1)