Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty

Knee Arthroplasty, Total Clinical Trial

Official title:

Selective Blocks for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465827
• Other study ID #: BispebjergH
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2015
• Last updated: June 4, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.

Description:

A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists' physical classification I-III

2. Age = 18 years undergoing primary unilateral total knee arthroplasty

Exclusion Criteria:

1. Inability to cooperate

2. Inability to speak and understand Danish

3. Allergy to any drugs used in the study

4. Drug or alcohol abuse

5. Pregnancy or nursing

6. Opioid abusers

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

• Knee Arthroplasty, Total

Intervention

Drug:
• nerve block with ropivacaine
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches
• nerve block with ropivacaine and with saline
nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline
• nerve block with saline
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively	NRS 0-10	24 hours	No
Secondary	Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively	NRS 0-10	24 hours	No
Secondary	Total opioid consumption	mg	24 hours	No
Secondary	Nausea and vomiting	NRS 0-10	24 hours	No
Secondary	Time to first mobilization	hours	24 hours	No
Secondary	Length of stay in recovery and hospital	hours	72 hours	No
Secondary	Number of clinical complications	total number	72 hours	No