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Sensory Distribution of Lateral Femoral Cutaneous Nerve Block

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ClinicalTrials.gov Identifier: NCT02957903
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Naestved Hospital
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
The purpose of this study is to investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be conducted in healthy volunteers in a blinded, randomized paired study.

Condition or disease Intervention/treatment Phase
Nerve Block Anesthesia, Local Pain, Postoperative Anatomical Distribution Drug: Ropivacaine Drug: Isotonic Saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Distribution of Lateral Femoral Cutaneous Nerve Block - A Randomized, Blinded, Paired Trial in Healthy Volunteers
Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A

Injection around the lateral femoral cutaneous nerve:

8 ml Ropivacaine 0.75 %.

Drug: Ropivacaine
All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
Other Name: 8 ml Ropivacaine 0.75 %

Placebo Comparator: Treatment B

Injection around the lateral femoral cutaneous nerve:

8 ml isotonic Saline.

Drug: Isotonic Saline
All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
Other Name: 8 ml isotonic Saline




Primary Outcome Measures :
  1. Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation [ Time Frame: 1 hour post-block ]
    Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.


Secondary Outcome Measures :
  1. Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by cold sensation [ Time Frame: 1 hour post-block ]
    Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.

  2. Difference in the percentage coverage of the incision (posterior approach) assessed by pin-prick [ Time Frame: 1 hour post-block ]
    Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).

  3. Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by pin-prick [ Time Frame: 1 hour post-block ]
    Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).

  4. The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.

  5. The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.

  6. The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterior-lateral approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.

  7. The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterior-lateral approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.

  8. The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.

  9. The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.

  10. The percentage of participants with no sensory function assessed (no pain detection) by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.

  11. The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach) [ Time Frame: 1 hour post-block ]
    The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.

  12. Estimation of the area with sensory loss assessed by cold sensation [ Time Frame: 1 hour post-block ]
    Estimation of the area with sensory loss (including photo documentation) assessed by cold sensation (alcohol soaked gauze) on the side given Ropivacaine and the side given saline. Marked with the incisions.

  13. Estimation of the area with sensory loss assessed by pin-prick [ Time Frame: 1 hour post-block ]
    Estimation of the area with sensory loss (including photo documentation) assessed by pin-prick (Von Frey filament) on the side given Ropivacaine and the side given saline. Marked with the incisions.

  14. The difference in MVIC (maximal voluntary isometric contraction) of the leg [ Time Frame: 1 hour post-block ]
    The difference in MVIC (maximal voluntary isometric contraction) of the leg between the side given Ropivacaine versus the side given saline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants who have given their written consent after understanding the content and limitations og the study.
  • ASA 1-2.
  • BMI ≥18 and ≤ 30

Exclusion Criteria:

  • Participants who can not cooperate in the study.
  • Participant who can not speak or understand danish.
  • Allergies to the drugs used in the study.
  • Alcohol consumption that exceeds 21 units per week.
  • Drug abuse by the investigators judgement.
  • Daily consumption of prescription required analgesic drugs within the last four weeks.
  • Consumption of over the counter analgesic drugs within the last 48 hours.
  • Neuromuscular defects, former surgery or trauma to the lower extremities.
  • Diabetes mellitus.
  • Pregnant women (women in the fertile age must have used safe contraception and test negative with a urine-HCG to be able to participate in the study).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957903


Locations
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Denmark
Zealand University Hospital, Køge
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Naestved Hospital
Investigators
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Study Chair: Daniel Hägi-Pedersen, MD, PhD Naestved Hospital
Principal Investigator: Kasper H Thybo, MD Naestved Hospital

Publications:
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02957903     History of Changes
Other Study ID Numbers: SM1-KHT-2016
2016-002643-41 ( EudraCT Number )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If data is requested by an editor it will be allowed
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents