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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344264
• Other study ID #: PROTOKOL - 001-2014 - KHTY
• Secondary ID: 2014-003730-10
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2015
• Last updated: September 24, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: Good Clinical Practice Unit
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ropivacaine
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.
• Saline
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.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology	Næstved	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Hägi-Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in VAS between NCFL and placebo during active 30 degrees hip flexion		45 min	No
Secondary	Difference in mean VAS between the groups during active hip flexion		15, 30, 45, 60, 75, 90 min	No
Secondary	Difference in mean VAS between the groups at rest		15, 30, 45, 60, 75, 90 min	No