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

Phase 4

Completed

• Conditions: Knee Arthroplasty, Total
• Interventions: Drug: nerve block with ropivacaine; Drug: nerve block with ropivacaine and with saline; Drug: nerve block with saline

• Registration Number: NCT02465827
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Study First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saphenous and obturator nerve block	nerve block with ropivacaine	5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of ropivacaine 0,75% for the obturator nerve block. Ropivacaine 0.75% for nerve blockades for both nerves mentioned.
Saphenous nerve block	nerve block with ropivacaine and with saline	5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Ropivacaine 0.75% for the saphenous nerve block and saline for the obturator nerve block
Placebo nerve block	nerve block with saline	5 ml of isotonic saline for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Saline for nerve blockades for both nerves mentioned.

Primary Outcome Measures

Name	Time	Method
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively	24 hours	NRS 0-10

Secondary Outcome Measures

Name	Time	Method
Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively	24 hours	NRS 0-10
Length of stay in recovery and hospital	72 hours	hours
Time to first mobilization	24 hours	hours
Total opioid consumption	24 hours	mg
Number of clinical complications	72 hours	total number
Nausea and vomiting	24 hours	NRS 0-10