Obturator Nerve Block, Total Hip Replacement
Conditions
Brief summary
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
Interventions
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
PROCEDURESham block
Injection as for obturator nerve block, but with placebo
PROCEDUREObturator nerve block
Postoperative obturator nerve block
Placebo
Sponsors
Elective Surgery Centre, Silkeborg Regional Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid dose 0-12 hour after total hip replacement | 0-12 hour after completion of total hip replacement | Cumulated dose of opioid 0-12 hour after total hip replacement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest at time of examination (numeric rating scale) | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | — |
| Pain at passive 90-degree hip flexion (numeric rating scale) | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | — |
| Worst pain during ambulation on the day of surgery | 5 hours after completion of total hip replacement | — |
| Time from completion of surgery to first dose of opioid | 24 hours after completion of total hip replacement | — |
| Intensity of nausea on time of examination (numeric rating scale) | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | — |
| Incidences of emesis 0-18 hours after total hip replacement. | 0-18 hours after completion of total hip replacement | — |
| Cumulated dose of ondansetron 0-18 hours after total hip replacement | 0-18 hours after completion of total hip replacement | — |
| Cumulated dose of opioid 12-18 hours after total hip replacement. | 12-18 hours after completion of total hip replacement | — |
| Length of stay on post anesthesia care unit after completion of total hip replacement | 24 hours after completion of total hip replacement | — |
| Length of stay on hospital after completion of total hip replacement | Up to 2 days | — |
| Ability to ambulate 5 hours after surgery | 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 | 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 | 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 | 0-4 hours after completion of total hip replacement | Time from end of operation until regain of normal sensibility on anterior femur. |
| Cumulated dose of droperidol 0-18 hours after total hip replacement | 0-18 hours after completion of total hip replacement | — |
Countries
Denmark
Outcome results
None listed