Clinical trial NCT03064165: Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade
Official title: Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obturator Nerve Block
Total Hip Replacement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Elective Surgery Centre, Silkeborg Regional Hospital
First posted: 2017-02-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Opioid dose 0-12 hour after total hip replacement
timeFrame: 0-12 hour after completion of total hip replacement
Secondary outcomes:
measure: Cumulated dose of opioid 12-18 hours after total hip replacement.
timeFrame: 12-18 hours after completion of total hip replacement
measure: Pain at rest at time of examination (numeric rating scale)
timeFrame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
measure: Pain at passive 90-degree hip flexion (numeric rating scale)
timeFrame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
measure: Worst pain during ambulation on the day of surgery
timeFrame: 5 hours after completion of total hip replacement
measure: Time from completion of surgery to first dose of opioid
timeFrame: 24 hours after completion of total hip replacement
measure: Intensity of nausea on time of examination (numeric rating scale)
timeFrame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
measure: Incidences of emesis 0-18 hours after total hip replacement.
timeFrame: 0-18 hours after completion of total hip replacement
measure: Cumulated dose of ondansetron 0-18 hours after total hip replacement
timeFrame: 0-18 hours after completion of total hip replacement
measure: Cumulated dose of droperidol 0-18 hours after total hip replacement
timeFrame: 0-18 hours after completion of total hip replacement
measure: Length of stay on post anesthesia care unit after completion of total hip replacement
timeFrame: 24 hours after completion of total hip replacement
measure: Length of stay on hospital after completion of total hip replacement
timeFrame: Up to 2 days
measure: Ability to ambulate 5 hours after surgery
timeFrame: 5 hours after completion of total hip replacement
measure: Motor control with operated leg
timeFrame: 5 hours after completion of total hip replacement
measure: Self-reported sleep quality the first night after total hip replacement
timeFrame: 24 hours after completion of total hip replacement
measure: Duration of spinal anesthesia
timeFrame: 0-4 hours after completion of total hip replacement
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Elective Surgery Centre
Study officials:
References:
citation: Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe 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:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.