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

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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

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 24, 2017
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE August 15, 2017
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03064165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Cumulated dose of opioid 12-18 hours after total hip replacement. [ Time Frame: 12-18 hours after completion of total hip replacement ]
  • 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 ]
  • 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 ]
  • Worst pain during ambulation on the day of surgery [ Time Frame: 5 hours after completion of total hip replacement ]
  • Time from completion of surgery to first dose of opioid [ Time Frame: 24 hours after completion of total hip replacement ]
  • 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 ]
  • Incidences of emesis 0-18 hours after total hip replacement. [ Time Frame: 0-18 hours after completion of total hip replacement ]
  • Cumulated dose of ondansetron 0-18 hours after total hip replacement [ Time Frame: 0-18 hours after completion of total hip replacement ]
  • Cumulated dose of droperidol 0-18 hours after total hip replacement [ Time Frame: 0-18 hours after completion of total hip replacement ]
  • Length of stay on post anesthesia care unit after completion of total hip replacement [ Time Frame: 24 hours after completion of total hip replacement ]
  • Length of stay on hospital after completion of total hip replacement [ Time Frame: Up to 2 days ]
  • 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
  • Motor control with operated leg [ Time Frame: 5 hours after completion of total hip replacement ]
    Physiotherapist evaluating motor control with operated leg during ambulation.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
  • Cumulated dose of opioid 12-24 hours after total hip replacement. [ Time Frame: 12-24 hours after completion of total hip replacement ]
  • 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 ]
  • Pain at maximal hip flexion (numeric rating scale) [ Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement ]
  • Maximal pain first 12 hours after total hip replacement (numeric rating scale) [ Time Frame: 0-12 hours after completion of total hip replacement ]
  • Maximal pain 12-24 hours after total hip replacement (numeric rating scale) [ Time Frame: 12-24 hours after completion of total hip replacement ]
  • Time from completion of surgery to first dose of opioid [ Time Frame: 24 hours after completion of total hip replacement ]
  • 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 ]
  • Incidences of emesis 0-24 hours after total hip replacement. [ Time Frame: 0-24 hours after completion of total hip replacement ]
  • Cumulated dose of ondansetron 0-24 hours after total hip replacement [ Time Frame: 0-24 hours after completion of total hip replacement ]
  • Cumulated dose of droperidol 0-24 hours after total hip replacement [ Time Frame: 0-24 hours after completion of total hip replacement ]
  • Length of stay on post anesthesia care unit after completion of total hip replacement [ Time Frame: 24 hours after completion of total hip replacement ]
  • Length of stay on hospital after completion of total hip replacement [ Time Frame: Up to 2 days ]
  • Time from completion of total hip replacement to the patient is able to walk [ Time Frame: Up to 2 days ]
  • Timed Up and Go-test-score [ Time Frame: 24 hours after completion of total hip replacement ]
  • Cumulated Ambulation-score [ Time Frame: 24 hours after completion of total hip replacement ]
  • 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.
  • Success rate for performance of obturator nerve block [ Time Frame: 24 hours after completion of total hip replacement ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade
Official Title  ICMJE Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
Brief Summary The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
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
  • Obturator Nerve Block
  • Total Hip Replacement
Intervention  ICMJE
  • Drug: Bupivacaine-epinephrine
    Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
  • Procedure: Sham block
    Injection as for obturator nerve block, but with placebo
  • Procedure: Obturator nerve block
    Postoperative obturator nerve block
  • Drug: Sodium Chloride 9mg/mL
    Placebo
Study Arms  ICMJE
  • Experimental: Obturator nerve block
    Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
    Interventions:
    • Drug: Bupivacaine-epinephrine
    • Procedure: Obturator nerve block
  • Placebo Comparator: Sham block
    Postoperative sham-block with normal saline.
    Interventions:
    • Procedure: Sham block
    • Drug: Sodium Chloride 9mg/mL
Publications * Nielsen ND, Runge C, Clemmesen L, Børglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Søballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23. pii: rapm-2018-100104. doi: 10.1136/rapm-2018-100104. [Epub ahead of print]

*   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: September 7, 2018)
62
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2017)
50
Actual Study Completion Date  ICMJE June 8, 2018
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03064165
Other Study ID Numbers  ICMJE HIP/FUSION#2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data will be shared through the Danish Data Archive.
Responsible Party Niels Dalsgaard Nielsen, University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Elective Surgery Centre, Silkeborg Regional Hospital
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date September 2018

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