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Completed

NCT Number: NCT02543801

A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.

Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

Exclusion criteria

  • Current use of opioid drugs
  • Revision surgery
  • Surgical complication (femoral fracture with implant insertion)
  • Inability to provide Informed Consent

Treatment and study plan

Liposomal bupivacaine

Drug

Periarticular injection

Other names: Exparel

Ropivacaine

Drug

Periarticular injection

Other names: Naropin

Bupivacaine

Drug

Included as an element of the Liposomal bupivacaine intervention periarticular injection

Other names: Marcaine

Clonidine

Drug

Included as an element of both interventions as a standard of care periarticular injection

Other names: Duraclon

Ketorolac

Drug

Included as an element of both interventions as a standard of care periarticular injection

Other names: Toradol

Epinephrine

Drug

Included as an element of both interventions as a standard of care periarticular injection

Other names: Adrenaline

Primary outcomes

  1. Pain Score

    Time frame: Starting post operatively and then every four hours up to 48 hours

    Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome

    Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated.

Secondary outcomes

  1. Narcotic Consumption

    Time frame: Starting immediately post operatively up to 48 hours

    Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.

  2. Length of Stay

    Time frame: Start of surgery to hospital discharge up to 140 hours

    Measured in hours

Sponsors and collaborators

Lead sponsor

Kootenai Health

Other

Registry information

Official study title

A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.