Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

March 30, 2017 updated by: St. Olavs Hospital

Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified.

Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • St.Olavs Hospital, Department of Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients receiving total hip arthroplasty in the study period

Exclusion Criteria:

  • contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
  • Patients who received general anaesthetic
  • patients who will get a different operation than standard direct lateral surgery
  • Patients with osteosynthesis to be removed in the same operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: LIA placebo
local infiltration anesthesia using saline i addition to multimodal analgesic regimen
Procedure: local infiltration anesthesia using saline
150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.
Procedure: Multimodal analgesic regimen
All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.
Experimental: LIA Ropivacaine
local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen
Procedure: Multimodal analgesic regimen
All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.
Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine
150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain assessed by numeric rating scale
Time Frame: 1 day (first postoperative day)
assessed by numeric rating scale
1 day (first postoperative day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Investigators

  • Principal Investigator: Tina Strømdal Wik, md phd, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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