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

January 24, 2024 updated by: Rajavithi Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transarticular multimodal drug infiltration
infiltration the mixture into intraarticular by catheter guided approach
Procedure: transarticular multimodal drug infiltration
as described previously
Active Comparator: periarticular multimodal drug infiltration

3 location of infiltration

  1. hip capsule
  2. gluteus medius and short external rotator
  3. gluteus maximus
Procedure: transarticular multimodal drug infiltration
as described previously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale at rest on postoperative day1st and 2nd
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
total morphine consumption in first 24 hours postoperative period via PCA pump
Time Frame: 1 week
1 week
total morphine consumption in whole postoperative period
Time Frame: 1 week
1 week
length of stay
Time Frame: 1 week
1 week
postoperative complication
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Investigators

  • Study Director: Peerapon Nantapong, MD, Rajavithi Hospital
  • Study Chair: Thakrit Chompoosang, MD, Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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