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

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ropivacaine
Epinephrine
Saline
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Hemiarthroplasty, Anesthesia, Local, Pain, Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ortopedisk forskningssenter, St.Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)

Single shot during surgery.150 ml saline

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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?
Total consumption of opioids on the first postoperative day

Full Information

First Posted
October 14, 2015
Last Updated
September 9, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02585011
Brief Title
Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
Official Title
Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 13, 2018 (Actual)
Study Completion Date
May 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Hemiarthroplasty, Anesthesia, Local, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single shot during surgery.150 ml saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Pain sensation during mobilization in the post-anesthesia care unit.
Description
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?
Time Frame
24 hours (day of surgery)
Secondary Outcome Measure Information:
Title
Pain during mobilization on the day after surgery
Description
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?
Time Frame
48 hours (first postoperative day)
Title
Total consumption of opioids on the first postoperative day
Time Frame
48 hrs (first postoperative day)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Foss, Phd
Organizational Affiliation
Ortopedisk forskningssenter, St.Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ortopedisk forskningssenter, St.Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

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

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