CompletedPhase 4ACTRN12615000844549

Does infiltration of local anaesthesia improve recovery after anterior hip replacement?

A prospective randomised double-blind placebo-controlled parallel-group two-arm superiority trial to determine the efficacy of local infiltration analgesia for anterior total hip replacement.


Sponsor

Dr Nicole Tan

Enrollment

160 participants

Start Date

Apr 20, 2016

Study Type

Interventional

Conditions

Summary

Major joint replacement surgery has an important role in improving the quality of life for many people. As Australia’s population grows and ages, joint replacement surgery will be performed more often. In 2014, over 11,000 hip joint replacements were performed in Victoria alone. Improved postoperative and longer-term mobility and comfort provides benefits not just for an individual, but also for the whole community. The anaesthetist’s role as a perioperative physician means that one clinical responsibility is to provide patients with rapid recovery to an appropriate level of function. This can be achieved by providing effective analgesia, which can be administered well, with few side effects. In practice, there is sometimes a trade-off in the balance between these goals. The widely used technique of infiltrating local anaesthetic into the hip joint during surgery is simple, with seemingly few side-effects. It is usually used together with analgesics such as paracetamol, anti-inflammatories and morphine tablets. However, recent studies have questioned its effectiveness at reducing pain in the traditional surgical approach to hip replacement. To date, no study has examined its effectiveness in the setting of less invasive surgery (anterior hip replacement). We aim to determine whether adding intraoperative local anaesthetic infiltration to standard multimodal oral analgesia will improve recovery after anterior hip replacement. 160 participants will be randomly allocated to receive infiltration of local anaesthetic or saline placebo during surgery. Any improvement in general wellbeing and mobility, or reduction in postoperative pain, will have a positive impact on a large surgical population. A negative result will provide evidence that the local anaesthetic infiltration technique should no longer be used for pain relief after anterior hip replacement surgery.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Patients aged 50 - 80 years undergoing primary unilateral anterior THR for osteoarthritis, who are able to provide informed consent.

Exclusion Criteria1

  • Patients will not be eligible if they take regular opioids other than codeine, have an allergy or contraindication to the proposed analgesic or anaesthetic technique, ASA > 3, BMI > 40, are pregnant, have undergone lower limb joint replacement in the preceding 6 months or are scheduled for any further surgery within 30 days.

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Interventions

This study will be a prospective, randomised, double-blind, placebo-controlled, parallel-group, two-arm superiority trial. Eligible participants will be aged 50-80 years undergoing primary unilateral

This study will be a prospective, randomised, double-blind, placebo-controlled, parallel-group, two-arm superiority trial. Eligible participants will be aged 50-80 years undergoing primary unilateral anterior THR for osteoarthritis. Participants will be assigned to intraoperative periarticular infiltration of 2.5ml/kg of 0.2% ropivacaine or 0.9% saline. All other care, including anaesthetic technique, postoperative analgesia and mobilisation programs, will be the same for both groups.


Locations(1)

Epworth Richmond - Richmond

VIC, Australia

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