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

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement
• Intervention / Treatment: Drug: Locoregional anesthesia; Drug: peroperative infiltration of local anesthetics

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • LYON cedex 03, France, 69437
    • Hôpital Edouard Herriot - Département d'anesthésie réanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of morphine consumed	Morphine consumption will be measured within the 72 hours following surgery	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest	Visual analogic pain scale (EVA) will be used to evaluate patient's pain at rest within the 72 hours following surgery	72 hours after surgery
Pain while moving	Visual analogic pain scale (EVA) will be used to evaluate patient's pain while moving within the 72 hours following surgery	72 hours after surgery
Time between intervention and first support by the upright posture in bipedal station.	Period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal station.	From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Time between intervention and resumption of the walk		From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: September 14, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: local analgesia; total hip replacement; local infiltrations
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 69HCL15_0189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No