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

Hip Arthropathy Clinical Trial

Official title:

Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663426
• Other study ID #: RCT impact OFA on THP
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2019
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Procedure:
• study group
High dose corticoids pre-operative and 24h postoperative Opioid free general anesthesia Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.
• control
No corticoids pre-operative. Opioid anesthesia Opioids post-operative after NSAID and paracetamol.

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR15	quality of recovery (QoR15) measured by 15 questions evaluating condition of recovery) scale 0 to 15 with 0 being very bad while 15 being maximum recovery possible or equal to pre operative state.	measured at 24 hours after surgery.
Primary	opioids postoperative	opioid use postoperative at 24 hours	measured at 24 hours after surgery.
Primary	CRP	Chronic reactive protein (CRP) change 24 h post-operative	measured at 24 hours after surgery.
Secondary	surgical condition	surgeon scores the surgical conditions on an adapted five-point Leyden scale	after surgery
Secondary	muscle damage	surgeon scores the muscle damage on an adapted five-point Leyden scale	after surgery
Secondary	length of hospital stay	number days patient stay in the hospital before discharge	until hospital discharge, maximum 7 days after surgery.
Secondary	complications	complications up to two weeks postoperative	2 weeks postoperative