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Completed

NCT Number: NCT02720471

Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Edouard Herriot - Département d'anesthésie réanimation

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Locoregional anesthesia

Drug

classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh

peroperative infiltration of local anesthetics

Drug

peroperative infiltration of local anesthetics

Primary outcomes

  1. Quantity of morphine consumed

    Time frame: 72 hours after surgery

    Morphine consumption will be measured within the 72 hours following surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ALRIAL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2016
Registry last updated
Aug 9, 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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