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OpenTrials
Completed

NCT Number: NCT02344264

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

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.

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Key information

Conditions

Pain, Postoperative Arthroplasty, Replacement, Hip Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Ropivacaine Signs and Symptoms Therapeutic Use

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology

Næstved, Danmark, 4700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Other names: Naropin

Saline

Drug

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Other names: NaCl, Placebo

Primary outcomes

  1. Difference in VAS between NCFL and placebo during active 30 degrees hip flexion

    Time frame: 45 min

Secondary outcomes

  1. Difference in mean VAS between the groups during active hip flexion

    Time frame: 15, 30, 45, 60, 75, 90 min

  2. Difference in mean VAS between the groups at rest

    Time frame: 15, 30, 45, 60, 75, 90 min

Sponsors and collaborators

Lead sponsor

Daniel Hägi-Pedersen

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2015
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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