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OpenTrials
Completed

NCT Number: NCT02585011

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

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.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ortopedisk forskningssenter, St.Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Epinephrine

Drug

Saline

Drug

Primary outcomes

  1. Pain sensation during mobilization in the post-anesthesia care unit.

    Time frame: 24 hours (day of 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?

Secondary outcomes

  1. Pain during mobilization on the day after surgery

    Time frame: 48 hours (first postoperative day)

    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?

  2. Total consumption of opioids on the first postoperative day

    Time frame: 48 hrs (first postoperative day)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2015
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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