Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study

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).

Study Overview

• Status: Completed
• Conditions: Hip Arthropathy
• Intervention / Treatment: Procedure: Nerve Block; Drug: Ropivacaine; Procedure: Periarticular Injection (PAI); Drug: Dex

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale-New Haven Hospital St Raphael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 patients will receive nerve block per standard of care; 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.	Procedure: Nerve Block; 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; Drug: Ropivacaine; 60 ml 0.2% ropivacaine
Active Comparator: Group 2 will NOT receive any nerve blocks.; 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.	Drug: Ropivacaine; 60 ml 0.2% ropivacaine; Procedure: Periarticular Injection (PAI); 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; Drug: Dex; 10 mg DEX/ 80 mg MPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 days
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.	Up to 5 days
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.	2 weeks post operation
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.	2 weeks post operation

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Jinlei Li, MD PhD FASA, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): June 19, 2021
• Study Completion (Actual): June 19, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2000025198

Drug and device information, study documents

• 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