Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.

NCT02728310 | Terminated Phase 3 DMC

• 1 other identifier: 0080580/12
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Incident and rest pain (using VAS score) at 72 hours after surgery

  The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  72 hours

Secondary Outcomes (5)

• Consumption of painkillers (in mg) at 72 hours after surgery

  72 hours

• Side effects (PONV) at 72 hours after surgery

  72 hours

• Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery

  72 hours

• Wound healing at 72 hours

  72 hours

• Improvement of rehabilitation at 72 hours

  72 hours

Study Arms (2)

Levobupivacaine infusion

ACTIVE COMPARATOR

1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected.

Drug: Levobupivacaine

Saline infusion

PLACEBO COMPARATOR

300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected.

Drug: Saline

Interventions

Levobupivacaine DRUG

An infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.

Also known as: Chiracaine

Levobupivacaine infusion

Saline DRUG

An infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.

Also known as: Saline solution

Saline infusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• American Society of Anaesthesiologists (ASA) physical status I-III
• total hip arthroplasty.

You may not qualify if:

• pregnancy
• body mass index (BMI) \>35
• allergy to local anaesthetics
• skeletal and/or muscle abnormalities of the spine
• primary and/or secondary neurological diseases
• psychiatric diseases
• history of chronic pain and/or neuropathic disorders
• history of drug abuse
• state of sepsis
• infection and/or tumours within the skin on the back
• primary or secondary coagulopathies
• primary or secondary heart, liver and renal failure.

Sponsors & Collaborators

• San Salvatore Hospital of L'Aquila: lead

Related Publications (2)

• Konopka JF, Hansen VJ, Rubash HE, Freiberg AA. Risk assessment tools used to predict outcomes of total hip and total knee arthroplasty. Orthop Clin North Am. 2015 Jul;46(3):351-62, ix-x. doi: 10.1016/j.ocl.2015.02.004. Epub 2015 Mar 24.

  PMID: 26043049 BACKGROUND

• Di Puccio F, Mattei L. Biotribology of artificial hip joints. World J Orthop. 2015 Jan 18;6(1):77-94. doi: 10.5312/wjo.v6.i1.77. eCollection 2015 Jan 18.

  PMID: 25621213 RESULT

MeSH Terms

Conditions

Pain

Interventions

Levobupivacaine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pierfrancesco Fusco, MD

  Anesthesia and Intensive care Unit, San Salvatore Academic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesist

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 5, 2016
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share