A Phase 4 interventional study of Bupivacaine-epinephrine and Sham block in Obturator Nerve Block and Total Hip Replacement, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
Drug: Bupivacaine-epinephrine · Procedure: Obturator nerve block
Postoperative sham-block with normal saline.
Procedure: Sham block · Drug: Sodium Chloride 9mg/mL
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
Injection as for obturator nerve block, but with placebo
Postoperative obturator nerve block
Placebo
Opioid dose 0-12 hour after total hip replacement
Cumulated dose of opioid 0-12 hour after total hip replacement
Time frame: 0-12 hour after completion of total hip replacement
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
Ability to sit, stand, walk with tall rollator and walk with crutches
Time frame: 5 hours after completion of total hip replacement
Motor control with operated leg
Physiotherapist evaluating motor control with operated leg during ambulation.
Time frame: 5 hours after completion of total hip replacement
Self-reported sleep quality the first night after 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.
Time frame: 24 hours after completion of total hip replacement
Duration of spinal anesthesia
Time from end of operation until regain of normal sensibility on anterior femur.
Time frame: 0-4 hours after completion of total hip replacement
Plan to share: Undecided — Data will be shared through the Danish Data Archive.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University of Aarhus