Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977454
• Other study ID #: 2000025198
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2019
• Est. completion date: June 19, 2021

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

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
• 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:
• Ropivacaine
60 ml 0.2% ropivacaine
• Dex
10 mg DEX/ 80 mg MPA

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital St Raphael	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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