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OpenTrials
Completed

NCT Number: NCT02359136

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Olavs Hospital, Department of Orthopedics

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

local infiltration anesthesia using Ropivacaine and Epinephrine

Procedure

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.

local infiltration anesthesia using saline

Procedure

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.

Multimodal analgesic regimen

Procedure

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.

Primary outcomes

  1. postoperative pain assessed by numeric rating scale

    Time frame: 1 day (first postoperative day)

    assessed by numeric rating scale

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 9, 2015
Registry last updated
Mar 31, 2017

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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