Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.

NCT ID: NCT03663426

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-11-01

Brief Summary

all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol.

control means no high steroid dose, opioids for anesthesia; paracetamol, NSAIDs and opioids as analgesia.

study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, NSAIDs and if needed opioids as escape.

Detailed Description

study group means for Anesthesia:

1. High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative

2. OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg).

3. Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization.

all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) < 3 by continuous infusion and monitoring of NMB.

Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation < 20% to reduce wound edema.

The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)

Conditions

Hip Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group opioid anesthesia

standard anesthesia using opioids

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: PROCEDURE

1. No corticoids pre-operative.

2. Opioid anesthesia

3. Opioids post-operative after NSAID and paracetamol.

study group opioid free anesthesia

opioid free anesthesia and high dose glucocorticoids

Group Type: EXPERIMENTAL

study group

Intervention Type: PROCEDURE

1. High dose corticoids pre-operative and 24h postoperative

2. Opioid free general anesthesia

3. Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.

Interventions

study group

1. High dose corticoids pre-operative and 24h postoperative

2. Opioid free general anesthesia

3. Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.

Intervention Type: PROCEDURE

control

1. No corticoids pre-operative.

2. Opioid anesthesia

3. Opioids post-operative after NSAID and paracetamol.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• arthroplasty by anterior approach

Exclusion Criteria

• allergy or impossible to use any of the drugs included
• revision procedure
• major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Jan Mulier

head of dep anesthesia & intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Lanckneus, MD

Role: STUDY_DIRECTOR

AZSint Jan AV

Locations

Azsintjan

Bruges, , Belgium

Countries

Belgium

Other Identifiers

RCT impact OFA on THP

Identifier Type: -

Identifier Source: org_study_id