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Completed

NCT Number: NCT03064165

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

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

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Key information

Conditions

Obturator Nerve Block Total Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Elective Surgery Centre

Silkeborg, DK-8600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-epinephrine

Drug

Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Sham Block

Procedure

Injection as for obturator nerve block, but with placebo

Obturator nerve block

Procedure

Postoperative obturator nerve block

Sodium Chloride 9mg/mL

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Elective Surgery Centre, Silkeborg Regional Hospital

Registry information

Official study title

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2017
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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