Continuous Saphenous Nerve Block for Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332045
• Other study ID #: H-3-2010-124
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: January 18, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Denmark	Anaestesiafdelingen, Frederiksberg Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Henning Lykke Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	VAS pain scores	3 days postoperative	No
Secondary	Opioid consumption		3 days postoperative	No
Secondary	physical therapy progress		3 days postoperative	No

External Links

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