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Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

Primary Purpose

Hip Arthropathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nerve Block
Periarticular Injection (PAI)
Ropivacaine
Dex
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective unilateral primary THA
  • All surgical approaches
  • American Society of Anesthesiologist (ASA) status I, II and III.

Exclusion Criteria:

  • Patient refusal;
  • Age less than 18 years
  • Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
  • Coagulopathy;

Sites / Locations

  • Yale-New Haven Hospital St Raphael

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 patients will receive nerve block per standard of care

Group 2 will NOT receive any nerve blocks.

Arm Description

Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.

Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.

Outcomes

Primary Outcome Measures

Daily Opioid Consumption
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.

Secondary Outcome Measures

Change in Pain Intensity While in Hospital
Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.
Length of Stay
The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.
Harris Hip Score
The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent.
Brief Pain Inventory: Interference
The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.

Full Information

First Posted
June 4, 2019
Last Updated
August 26, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03977454
Brief Title
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Official Title
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).
Detailed Description
To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes: Primary outcome: Daily opioid consumption Secondary outcomes: Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays. Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection. When results were entered, the detailed description was updated to reflect the outcome measures used in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 patients will receive nerve block per standard of care
Arm Type
Experimental
Arm Description
Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.
Arm Title
Group 2 will NOT receive any nerve blocks.
Arm Type
Active Comparator
Arm Description
Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.
Intervention Type
Procedure
Intervention Name(s)
Nerve Block
Intervention Description
Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
Intervention Type
Procedure
Intervention Name(s)
Periarticular Injection (PAI)
Intervention Description
Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
60 ml 0.2% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Dex
Intervention Description
10 mg DEX/ 80 mg MPA
Primary Outcome Measure Information:
Title
Daily Opioid Consumption
Description
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Change in Pain Intensity While in Hospital
Description
Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.
Time Frame
Up to 2 days
Title
Length of Stay
Description
The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.
Time Frame
Up to 5 days
Title
Harris Hip Score
Description
The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent.
Time Frame
2 weeks post operation
Title
Brief Pain Inventory: Interference
Description
The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.
Time Frame
2 weeks post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective unilateral primary THA All surgical approaches American Society of Anesthesiologist (ASA) status I, II and III. Exclusion Criteria: Patient refusal; Age less than 18 years Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team; Coagulopathy;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlei Li, MD PhD FASA
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital St Raphael
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

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