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| Name | Class |
|---|---|
| Elective Surgery Centre, Silkeborg Regional Hospital | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obturator nerve block | Experimental | Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL. |
|
| Sham block | Placebo Comparator | Postoperative sham-block with normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-epinephrine | Drug | Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid dose 0-12 hour after total hip replacement | Cumulated dose of opioid 0-12 hour after total hip replacement | 0-12 hour after completion of total hip replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated dose of opioid 12-18 hours after total hip replacement. | 12-18 hours after completion of total hip replacement | |
| Pain at rest at time of examination (numeric rating scale) | 1, 2, 5, 7 and 24 hours after completion of total hip replacement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elective Surgery Centre | Silkeborg | DK-8600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30679337 | Derived | 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. |
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Data will be shared through the Danish Data Archive.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2020 | |
| Reset | Nov 25, 2020 | |
| Release | May 10, 2021 | |
| Reset | Jun 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2020 | Nov 25, 2020 | |||
| May 10, 2021 |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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 |
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| 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 droperidol 0-18 hours after total hip replacement | 0-18 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 | Ability to sit, stand, walk with tall rollator and walk with crutches | 5 hours after completion of total hip replacement |
| Motor control with operated leg | Physiotherapist evaluating motor control with operated leg during ambulation. | 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. | 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. | 0-4 hours after completion of total hip replacement |
| Jun 2, 2021 |
| D017670 |
| Sodium Compounds |