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Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Approved by the Danish Medicines Agency |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of opioids | 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 5 days postoperatively |
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Inclusion Criteria:
Intertrochanteric hip fracture
Fracture due to low energy trauma
Ability to understand danish and give informed consent
Ability to walk before trauma
Indication for osteosynthesis
•≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soren Overgaard, MD, DmSc | Odense University Hospital, DK-5000 Odense C, Denmark | Study Chair |
| Rune Dueholm Bech, MD | Odense University Hospital, DK-5000 Odense C, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | DK | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30538796 | Derived | Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline |
| Drug |
Approved by the Danish Medicines Agency |
|
| D007869 |
| Leg Injuries |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |