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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02728310
• Other study ID #: 0080580/12
• Status: Terminated
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2020
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consumption of painkillers (in mg) at 72 hours after surgery	The equianalgesic dose (in mg) of morphine	72 hours
Secondary	Side effects (PONV) at 72 hours after surgery	Time to have post-operative nausea and vomiting (in minutes)	72 hours
Secondary	Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery	Presence or not of epilepsy	72 hours
Secondary	Wound healing at 72 hours	Number of infections of surgical wound.	72 hours
Secondary	Improvement of rehabilitation at 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.	72 hours