Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

NCT ID: NCT03977454

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2021-06-19

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.

Conditions

Hip Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and

2. 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.

Group Type: EXPERIMENTAL

Nerve Block

Intervention Type: PROCEDURE

Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.

1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA

2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA

Ropivacaine

Intervention Type: DRUG

60 ml 0.2% ropivacaine

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.

Group Type: ACTIVE_COMPARATOR

Periarticular Injection (PAI)

Intervention Type: PROCEDURE

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

Ropivacaine

Intervention Type: DRUG

60 ml 0.2% ropivacaine

Dex

Intervention Type: DRUG

10 mg DEX/ 80 mg MPA

Interventions

Nerve Block

Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.

1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA

2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA

Intervention Type: 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

Intervention Type: PROCEDURE

Ropivacaine

60 ml 0.2% ropivacaine

Intervention Type: DRUG

Dex

10 mg DEX/ 80 mg MPA

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinlei Li, MD PhD FASA

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital St Raphael

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000025198

Identifier Type: -

Identifier Source: org_study_id