Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty

Daniel Hägi-Pedersen

Status and phase: Completed; Phase 4

Conditions: Arthroplasty, Replacement, Hip; Therapeutic Use; Ropivacaine; Pain, Postoperative

Treatments: Drug: Saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02344264

PROTOKOL - 001-2014 - KHTY

2014-003730-10 (EudraCT Number)

Details and patient eligibility

About

The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.

Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Enrollment: 60 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication.
• informed consent
• ASA 1-3
• BMI 18-40

Exclusion criteria

• Unable to communicate in danish
• Allergic reactions toward drugs used
• Abuse of alcohol/drugs
• Unable to cooperate
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

RP

Other group

Description:

first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml

Treatment:

Drug: Ropivacaine

Drug: Saline

PR

Other group

Description:

first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml

Treatment:

Drug: Ropivacaine

Drug: Saline