Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty

Study Overview
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Brief Summary
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At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.

Official Title
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Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Epinephrine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for hemiarthroplasty at St. Olavs Hospital competent and willing to give consent able to be mobilized in the PACU and in the trauma ward unit. Exclusion Criteria: contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene receiving general anesthesia patients operated on with an approach different to standard direct lateral surgery receiving osteosyntheses receiving femoral block less than 4 hours before surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml) | Drug: Ropivacaine<br> <br> Drug: Epinephrine<br> <br> |
| Placebo Comparator: Placebo<br>Single shot during surgery.150 ml saline | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation during mobilization in the post-anesthesia care unit. | Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now? | 24 hours (day of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during mobilization on the day after surgery | Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now? | 48 hours (first postoperative day) | 
| Total consumption of opioids on the first postoperative day |  | 48 hrs (first postoperative day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiarthroplasty, Anesthesia, Local, Pain, Postoperative