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

• ClinicalTrials.gov Identifier: NCT02728310
• Recruitment Status: Terminated
• First Posted: April 5, 2016
• Last Update Posted: August 12, 2020
• Sponsor: San Salvatore Hospital of L'Aquila
• Information provided by (Responsible Party): Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Levobupivacaine; Drug: Saline	Phase 3

Detailed Description:

Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial
• Study Start Date: September 2012
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Levobupivacaine infusion; 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; 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.; Other Name: Chiracaine
Placebo Comparator: Saline infusion; 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; 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.; Other Name: Saline solution

Outcome Measures

Primary Outcome Measures :

1. Incident and rest pain (using VAS score) at 72 hours after surgery [ Time Frame: 72 hours ]
   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").

Secondary Outcome Measures :

1. Consumption of painkillers (in mg) at 72 hours after surgery [ Time Frame: 72 hours ]
   The equianalgesic dose (in mg) of morphine
2. Side effects (PONV) at 72 hours after surgery [ Time Frame: 72 hours ]
   Time to have post-operative nausea and vomiting (in minutes)
3. Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery [ Time Frame: 72 hours ]
   Presence or not of epilepsy
4. Wound healing at 72 hours [ Time Frame: 72 hours ]
   Number of infections of surgical wound.
5. Improvement of rehabilitation at 72 hours [ Time Frame: 72 hours ]
   Our total hip arthroplasy rehabilitation protocol is focused on the following manoeuvres: contraction of the gluteal and quadricipital muscles, passive and active mobilization of the hip joint, passive and active mobilization of the knee and walking with crutches and a walker.the improvement of rehabilitation manoeuvres has been evaluated in a four-step scale: 0-no improvement; 1- slight improvement, 2- good improvement; 3- great improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 18-90 years of age
• American Society of Anaesthesiologists (ASA) physical status I-III
• total hip arthroplasty.

Exclusion Criteria:

• 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.

Contacts and Locations

Sponsors and Collaborators

San Salvatore Hospital of L'Aquila

Investigators

• Principal Investigator: Pierfrancesco Fusco, MD; Anesthesia and Intensive care Unit, San Salvatore Academic Hospital

More Information

Publications of Results:

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. Review.

Other Publications:

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. Review.

• Responsible Party: Emiliano Petrucci, Anesthesist, San Salvatore Hospital of L'Aquila
• ClinicalTrials.gov Identifier: NCT02728310
• Other Study ID Numbers: 0080580/12
• First Posted: April 5, 2016
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Levobupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents