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Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

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ClinicalTrials.gov Identifier: NCT02289937
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Daniel Hägi-Pedersen, Naestved Hospital

Brief Summary:
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Anesthesia, Conduction Arthroplasty, Replacement, Hip Drug: Ropivacaine Drug: Placebo Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: Ropivacaine
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
Drug: Ropivacaine
Other Name: Naropin

Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Placebo Comparator: Placebo
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
Drug: Placebo
Other Name: Saline, NaCl

Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively



Primary Outcome Measures :
  1. VAS-score 4 hours postoperative during movement [ Time Frame: 4 hours postoperative ]
    VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.


Secondary Outcome Measures :
  1. VAS-score 0-24 hours postoperative during movement [ Time Frame: 0-24 hours postoperatively ]
    VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.

  2. VAS-score 0-24 hours postoperative at rest [ Time Frame: 0-24 hours postoperatively ]
    VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.

  3. Oxynorm consumption [ Time Frame: 0-24 hours postoperative ]
    Oxynorm consumption 24 hours postoperative

  4. time to first oxynorm requirement [ Time Frame: 0-24 hours postoperatively ]
  5. Mobilization [ Time Frame: 0-24 hours postoperatively ]
    time to first mobilization

  6. Mobilization [ Time Frame: 0-24 hours postoperatively ]
    Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized

  7. Length of stay [ Time Frame: 0-7 days postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total hip replacement

Exclusion Criteria:

  • general anaesthesia
  • Allergy to local anesthetics of the amide type
  • Revision surgery
  • Bilateral surgery
  • Chronic pain patient
  • Women in the fertile age

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): NCT02289937


Sponsors and Collaborators
Daniel Hägi-Pedersen
Investigators
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Study Chair: Daniel Hägi-Pedersen, M.D., Ph.D. Naestved Hospital, Department of Anaesthesiology

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Responsible Party: Daniel Hägi-Pedersen, Consultant, Naestved Hospital
ClinicalTrials.gov Identifier: NCT02289937     History of Changes
Other Study ID Numbers: 001-2013
2013-004501-12 ( EudraCT Number )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Daniel Hägi-Pedersen, Naestved Hospital:
Postoperative pain
regional anaesthesia
total hip replacement
nervus cutaneous femoral lateralis
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