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

NCT02344264 | Completed Phase 4 DMC

• 2 other identifiers: PROTOKOL - 001-2014 - KHTY2014-003730-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

US guided nerve block; Total hip Arthroplasty; NCFL; nervus cutaneous femoralis lateralis

Outcome Measures

Primary Outcomes (1)

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

  45 min

Secondary Outcomes (2)

• Difference in mean VAS between the groups during active hip flexion

  15, 30, 45, 60, 75, 90 min

• Difference in mean VAS between the groups at rest

  15, 30, 45, 60, 75, 90 min

Study Arms (2)

RP

OTHER

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

Drug: Ropivacaine; Drug: Saline

PR

OTHER

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

Drug: Ropivacaine; Drug: Saline

Interventions

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.

Also known as: Naropin

PR; RP

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.

Also known as: NaCl, Placebo

PR; RP

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Daniel Hägi-Pedersen: lead

Study Sites (1)

Department of Anaesthesiology

Næstved, Danmark, 4700, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel Hägi-Pedersen, Ph.D.

  Naestved Hospital, Department of Anaesthesiology

  STUDY CHAIR

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: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

DK (1)