Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064165
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Elective Surgery Centre, Silkeborg Regional Hospital
Information provided by (Responsible Party):
Niels Dalsgaard Nielsen, University of Aarhus

Brief Summary:
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Condition or disease Intervention/treatment Phase
Obturator Nerve Block Total Hip Replacement Drug: Bupivacaine-epinephrine Procedure: Sham block Procedure: Obturator nerve block Drug: Sodium Chloride 9mg/mL Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: Obturator nerve block
Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
Drug: Bupivacaine-epinephrine
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Procedure: Obturator nerve block
Postoperative obturator nerve block

Placebo Comparator: Sham block
Postoperative sham-block with normal saline.
Procedure: Sham block
Injection as for obturator nerve block, but with placebo

Drug: Sodium Chloride 9mg/mL
Placebo




Primary Outcome Measures :
  1. Opioid dose 0-12 hour after total hip replacement [ Time Frame: 0-12 hour after completion of total hip replacement ]
    Cumulated dose of opioid 0-12 hour after total hip replacement


Secondary Outcome Measures :
  1. Cumulated dose of opioid 12-18 hours after total hip replacement. [ Time Frame: 12-18 hours after completion of total hip replacement ]
  2. Pain at rest at time of examination (numeric rating scale) [ Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement ]
  3. Pain at passive 90-degree hip flexion (numeric rating scale) [ Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement ]
  4. Worst pain during ambulation on the day of surgery [ Time Frame: 5 hours after completion of total hip replacement ]
  5. Time from completion of surgery to first dose of opioid [ Time Frame: 24 hours after completion of total hip replacement ]
  6. Intensity of nausea on time of examination (numeric rating scale) [ Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement ]
  7. Incidences of emesis 0-18 hours after total hip replacement. [ Time Frame: 0-18 hours after completion of total hip replacement ]
  8. Cumulated dose of ondansetron 0-18 hours after total hip replacement [ Time Frame: 0-18 hours after completion of total hip replacement ]
  9. Cumulated dose of droperidol 0-18 hours after total hip replacement [ Time Frame: 0-18 hours after completion of total hip replacement ]
  10. Length of stay on post anesthesia care unit after completion of total hip replacement [ Time Frame: 24 hours after completion of total hip replacement ]
  11. Length of stay on hospital after completion of total hip replacement [ Time Frame: Up to 2 days ]
  12. Ability to ambulate 5 hours after surgery [ Time Frame: 5 hours after completion of total hip replacement ]
    Ability to sit, stand, walk with tall rollator and walk with crutches

  13. Motor control with operated leg [ Time Frame: 5 hours after completion of total hip replacement ]
    Physiotherapist evaluating motor control with operated leg during ambulation.

  14. Self-reported sleep quality the first night after total hip replacement [ Time Frame: 24 hours after completion of total hip replacement ]
    Self-reported sleep quality on a 3-point-scale: 2 = Undisturbed sleep; 1 = Sleep disturbed by other reasons than pain; 0 = Sleep disturbed by pain.

  15. Duration of spinal anesthesia [ Time Frame: 0-4 hours after completion of total hip replacement ]
    Time from end of operation until regain of normal sensibility on anterior femur.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients for primary hip replacement in spinal anesthesia
  • Age >= 18 years
  • American Society of Anesthesiologists physical status classification score I-III
  • Informed consent

Exclusion Criteria:

  • Lacking the ability to corporate
  • Lacking the ability to speak danish
  • Planned discharge on the same day of surgery
  • Neuropathy of the lower extremities
  • Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
  • Contraindications for dexamethasone
  • Chronic opioid demanding pain
  • Pregnancy
  • Allergy towards one or both investigatory medicinal products
  • Active treatment with amiodarone
  • Active treatment with verapamil
  • Active treatment with corticosteroids

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): NCT03064165


Locations
Layout table for location information
Denmark
Elective Surgery Centre
Silkeborg, Denmark, DK-8600
Sponsors and Collaborators
University of Aarhus
Elective Surgery Centre, Silkeborg Regional Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Niels Dalsgaard Nielsen, MD, PhD-fellow, University of Aarhus
ClinicalTrials.gov Identifier: NCT03064165     History of Changes
Other Study ID Numbers: HIP/FUSION#2
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared through the Danish Data Archive.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents