Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement

NCT02720471 | Completed Phase 3

• 1 other identifier: 69HCL15_0189
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Keywords

local analgesia; total hip replacement; local infiltrations

Outcome Measures

Primary Outcomes (1)

• Quantity of morphine consumed

  Morphine consumption will be measured within the 72 hours following surgery

  72 hours after surgery

Secondary Outcomes (4)

• Pain at rest

  72 hours after surgery

• Pain while moving

  72 hours after surgery

• Time between intervention and 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

Study Arms (2)

Locoregional anesthesia

ACTIVE COMPARATOR

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

Peroperative infiltration

EXPERIMENTAL

Peroperative infiltration of local anesthetics (IAL) will be performed in patients of this arm

Drug: peroperative infiltration of local anesthetics

Interventions

Locoregional anesthesia DRUG

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

Locoregional anesthesia

peroperative infiltration of local anesthetics DRUG

peroperative infiltration of local anesthetics

Peroperative infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot - Département d'anesthésie réanimation

Lyon, 69437, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: March 28, 2016
• Study Start: September 14, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

FR (1)