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Completed

NCT Number: NCT05325671

Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial

This research aim to improve postoperative outcome in total hip arthroplasty(THA) by using local mixture infiltration as bupivacaine + NSAID + epinephrine + tranxemic acid. In the present time these mixture components has shown to improve THA outcome by aspect of postoperative pain control, postoperative opioid consumption, postoperative bleeding, LOS and postoperative rehabilitation without increasing complication but the accuracy of infiltration technique which gives the best outcome has not been yet discovered.Recently study by Hashimoto et al has risen that these technique can be administrated by both periarticular and intra-articular approach.By considering the complexity of human anatomy around the hip tissue we assume that the intra-articular(transarticular) may given equivalence (may be better) outcome with lowering procedural related complication comparing to periarticular infiltration approach.

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Key information

Conditions

Pain, Post Operative Arthroplasty Complications Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patient who would go on cemented and cementless THA
  • age 45-60 years of age
  • voluntary decision exclusion criteria
  • bilateral THA
  • revision surgery
  • history of pelvic and hip surgery previously
  • allergy to medication in protocol
  • CKD stage 4-5, chronic liver disease with Child Pugh B or C
  • pregnancy
  • history of hip injection
  • U/D
  • hypercoagulable state
  • abnormal laboratory coagulation study as INR > 1.4 or aPTT > 1.4
  • abnormal platelet function
  • thrombocytopenia
  • PE , DVT, ischemic stroke, CAD/ischemic heart disease
  • use of anticoagulant or hormonal usage
  • anesthesia by general anesthesia or additional nerve block
  • can not understand PCA usage
  • use postopertive wound drainage

Treatment and study plan

transarticular multimodal drug infiltration

Procedure

as described previously

Primary outcomes

  1. Visual analogue scale at rest on postoperative day1st and 2nd

    Time frame: 1 week

Secondary outcomes

  1. total morphine consumption in first 24 hours postoperative period via PCA pump

    Time frame: 1 week

  2. total morphine consumption in whole postoperative period

    Time frame: 1 week

  3. length of stay

    Time frame: 1 week

  4. postoperative complication

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2022
Registry last updated
Jan 25, 2024

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.

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