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

S

St. Olavs Hospital

Status

Completed

Conditions

Femoral Neck Fractures

Treatments

Drug: Saline
Drug: Epinephrine
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02585011
2015/1201

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

123 participants in 2 patient groups, including a placebo group

Ropivacaine
Experimental group
Description:
Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)
Treatment:
Drug: Ropivacaine
Drug: Epinephrine
Placebo
Placebo Comparator group
Description:
Single shot during surgery.150 ml saline
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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