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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

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE November 13, 2014
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • 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.
  • 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.
  • Oxynorm consumption [ Time Frame: 0-24 hours postoperative ]
    Oxynorm consumption 24 hours postoperative
  • time to first oxynorm requirement [ Time Frame: 0-24 hours postoperatively ]
  • Mobilization [ Time Frame: 0-24 hours postoperatively ]
    time to first mobilization
  • 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
  • Length of stay [ Time Frame: 0-7 days postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
Official Title  ICMJE Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Anesthesia, Conduction
  • Arthroplasty, Replacement, Hip
Intervention  ICMJE
  • Drug: Ropivacaine
    Other Name: Naropin
  • Drug: Placebo
    Other Name: Saline, NaCl
  • Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Study Arms  ICMJE
  • Experimental: Ropivacaine
    8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
    Interventions:
    • Drug: Ropivacaine
    • 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
    Interventions:
    • Drug: Placebo
    • Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02289937
Other Study ID Numbers  ICMJE 001-2013
2013-004501-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Hägi-Pedersen, Naestved Hospital
Study Sponsor  ICMJE Daniel Hägi-Pedersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Daniel Hägi-Pedersen, M.D., Ph.D. Naestved Hospital, Department of Anaesthesiology
PRS Account Naestved Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP