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Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement (ALRIAL)

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ClinicalTrials.gov Identifier: NCT02720471
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier.

The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours.

The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.


Condition or disease Intervention/treatment Phase
Total Hip Replacement Drug: Locoregional anesthesia Drug: peroperative infiltration of local anesthetics Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement
Study Start Date : September 14, 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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Arm Intervention/treatment
Active Comparator: Locoregional anesthesia
Classical locoregional analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh will be performed in patients of this arm
Drug: Locoregional anesthesia
classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh

Experimental: Peroperative infiltration
Peroperative infiltration of local anesthetics (IAL) will be performed in patients of this arm
Drug: peroperative infiltration of local anesthetics
peroperative infiltration of local anesthetics




Primary Outcome Measures :
  1. Quantity of morphine consumed [ Time Frame: 72 hours after surgery ]
    Morphine consumption will be measured within the 72 hours following surgery


Secondary Outcome Measures :
  1. Pain at rest [ Time Frame: 72 hours after surgery ]
    Visual analogic pain scale (EVA) will be used to evaluate patient's pain at rest within the 72 hours following surgery

  2. Pain while moving [ Time Frame: 72 hours after surgery ]
    Visual analogic pain scale (EVA) will be used to evaluate patient's pain while moving within the 72 hours following surgery

  3. Time between intervention and first support by the upright posture in bipedal station. [ Time Frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery ]
    Period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal station.

  4. Time between intervention and resumption of the walk [ Time Frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women > or = 18 years old
  • Surgery for total hip replacement (THR)
  • Unilateral THR
  • First THR
  • THR planned because of a degenerative disease or after a traumatism
  • Whatever the technique of anesthesia (general anesthesia or intra thecal anesthesia)
  • Whatever the surgery technique/surgical approach
  • Patient with a social security protection
  • Patient not under juridic protection
  • Agreement for the study signed by the patient himself or, if he is not able to sign, by his trusted person.

Exclusion Criteria:

  • Patient Refusal
  • Second hip replacement
  • Pregnancy or breastfeeding
  • Porphyria
  • Risks to have methemoglobinemia (G6PD deficit, hemoglobin disease)
  • BMI> 40 kg/m2 ou < 18 kg/m2
  • Allergy to any of the drugs used in this study
  • Contraindication to any of the technic used in this study
  • Factors wich could influence the perception of pain (depression, dementia, psychiatric illness, neurologic disease with sensitivity troubles)
  • Usual consumption of opioids
  • Systemic or articular infection
  • Participation to an other research that could interfere in this study

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): NCT02720471


Locations
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France
Hôpital Edouard Herriot - Département d'anesthésie réanimation
LYON cedex 03, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02720471     History of Changes
Other Study ID Numbers: 69HCL15_0189
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
local analgesia
total hip replacement
local infiltrations
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents