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

Primary Purpose

Pain, Postoperative, Ropivacaine, Therapeutic Use

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Daniel Hägi-Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring US guided nerve block, Total hip Arthroplasty, NCFL, nervus cutaneous femoralis lateralis

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

RP

PR

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in mean VAS between the groups during active hip flexion
Difference in mean VAS between the groups at rest

Full Information

First Posted
January 16, 2015
Last Updated
September 24, 2015
Sponsor
Daniel Hägi-Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT02344264
Brief Title
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Official Title
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Hägi-Pedersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Ropivacaine, Therapeutic Use, Arthroplasty, Replacement, Hip
Keywords
US guided nerve block, Total hip Arthroplasty, NCFL, nervus cutaneous femoralis lateralis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RP
Arm Type
Other
Arm Description
first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml
Arm Title
PR
Arm Type
Other
Arm Description
first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
NaCl, Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
Time Frame
45 min
Secondary Outcome Measure Information:
Title
Difference in mean VAS between the groups during active hip flexion
Time Frame
15, 30, 45, 60, 75, 90 min
Title
Difference in mean VAS between the groups at rest
Time Frame
15, 30, 45, 60, 75, 90 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hägi-Pedersen, Ph.D.
Organizational Affiliation
Naestved Hospital, Department of Anaesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anaesthesiology
City
Næstved
State/Province
Danmark
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

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

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