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

San Salvatore Hospital of L'Aquila

Status and phase: Terminated; Phase 3

Conditions: Pain

Treatments: Drug: Levobupivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02728310

0080580/12

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Levobupivacaine infusion

Active Comparator group

Description:

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.

Treatment:

Drug: Levobupivacaine

Saline infusion

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline