Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement

Total Hip Replacement Clinical Trial

— ALRIAL  

Official title:

Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720471
• Other study ID #: 69HCL15_0189
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2015
• Last updated: August 8, 2017
• Start date: September 14, 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Drug:
• Locoregional anesthesia
classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh
• peroperative infiltration of local anesthetics
peroperative infiltration of local anesthetics

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Département d'anesthésie réanimation	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of morphine consumed	Morphine consumption will be measured within the 72 hours following surgery	72 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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