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

NCT ID: NCT02585011

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-05-13

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.

Detailed Description

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Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Placebo

Single shot during surgery.150 ml saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Saline

Intervention Type DRUG

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olav Foss, Phd

Role: STUDY_DIRECTOR

Ortopedisk forskningssenter, St.Olavs Hospital

Locations

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Ortopedisk forskningssenter, St.Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2015/1201

Identifier Type: -

Identifier Source: org_study_id

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