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

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ClinicalTrials.gov Identifier: NCT02359136
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine Procedure: local infiltration anesthesia using saline Procedure: Multimodal analgesic regimen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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: 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.

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.




Primary Outcome Measures :
  1. postoperative pain assessed by numeric rating scale [ Time Frame: 1 day (first postoperative day) ]
    assessed by numeric rating scale



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359136


Locations
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Norway
St.Olavs Hospital, Department of Orthopedics
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Investigators
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Principal Investigator: Tina Strømdal Wik, md phd St. Olavs Hospital

Publications of Results:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02359136     History of Changes
Other Study ID Numbers: 2012/1999
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Arthroplasty, Replacement, Hip
Anesthesia, Local
Ropivacaine
Randomized controlled trial
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epinephrine
Racepinephrine
Anesthetics
Ropivacaine
Epinephryl borate
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents