Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty
Selective Blocks for Total Knee Arthroplasty
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedJune 9, 2015
June 1, 2015
1.2 years
June 2, 2015
June 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
NRS 0-10
24 hours
Secondary Outcomes (6)
Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively
24 hours
Total opioid consumption
24 hours
Nausea and vomiting
24 hours
Time to first mobilization
24 hours
Length of stay in recovery and hospital
72 hours
- +1 more secondary outcomes
Study Arms (3)
Saphenous and obturator nerve block
ACTIVE COMPARATOR5 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
ACTIVE COMPARATOR5 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
PLACEBO COMPARATOR5 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.
Interventions
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches
nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists' physical classification I-III
- Age ≥ 18 years undergoing primary unilateral total knee arthroplasty
You may not qualify if:
- Inability to cooperate
- Inability to speak and understand Danish
- Allergy to any drugs used in the study
- Drug or alcohol abuse
- Pregnancy or nursing
- Opioid abusers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass professor, PhD
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 9, 2015
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 9, 2015
Record last verified: 2015-06