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

Primary Purpose

Pain, Post Operative, Arthroplasty Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
transarticular multimodal drug infiltration
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Post Operative focused on measuring total hip arthroplasty, transarticular multimodal drug infiltration, periarticular multimodal drug infiltration

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transarticular multimodal drug infiltration

periarticular multimodal drug infiltration

Arm Description

infiltration the mixture into intraarticular by catheter guided approach

3 location of infiltration hip capsule gluteus medius and short external rotator gluteus maximus

Outcomes

Primary Outcome Measures

Visual analogue scale at rest on postoperative day1st and 2nd

Secondary Outcome Measures

total morphine consumption in first 24 hours postoperative period via PCA pump
total morphine consumption in whole postoperative period
length of stay
postoperative complication

Full Information

First Posted
April 5, 2022
Last Updated
April 5, 2022
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05325671
Brief Title
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Official Title
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 5, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative, Arthroplasty Complications
Keywords
total hip arthroplasty, transarticular multimodal drug infiltration, periarticular multimodal drug infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transarticular multimodal drug infiltration
Arm Type
Experimental
Arm Description
infiltration the mixture into intraarticular by catheter guided approach
Arm Title
periarticular multimodal drug infiltration
Arm Type
Active Comparator
Arm Description
3 location of infiltration hip capsule gluteus medius and short external rotator gluteus maximus
Intervention Type
Procedure
Intervention Name(s)
transarticular multimodal drug infiltration
Intervention Description
as described previously
Primary Outcome Measure Information:
Title
Visual analogue scale at rest on postoperative day1st and 2nd
Time Frame
1 week
Secondary Outcome Measure Information:
Title
total morphine consumption in first 24 hours postoperative period via PCA pump
Time Frame
1 week
Title
total morphine consumption in whole postoperative period
Time Frame
1 week
Title
length of stay
Time Frame
1 week
Title
postoperative complication
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peerapon Nantapong, MD
Phone
+6695-6800444
Email
peeraponthong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thakrit Chompoosang, MD
Phone
+6684-6461916
Email
tk_ortho@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peerapon Nantapong, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thakrit Chompoosang, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajavithi Hospital
Phone
+6695-6800444
Email
peeraponthong@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29939641
Citation
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Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial

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