Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

NCT03977454 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2000025198
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Pain Intensity While in Hospital

  Up to 2 days

• Length of Stay

  Up to 5 days

• Harris Hip Score

  2 weeks post operation

• Brief Pain Inventory: Interference

  2 weeks post operation

Study Arms (2)

Group 1 patients will receive nerve block per standard of care

EXPERIMENTAL

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.

Procedure: Nerve Block; Drug: Ropivacaine

Group 2 will NOT receive any nerve blocks.

ACTIVE COMPARATOR

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.

Procedure: Periarticular Injection (PAI); Drug: Ropivacaine; Drug: Dex

Interventions

Nerve Block 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

Group 1 patients will receive nerve block per standard of care

Periarticular Injection (PAI) 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

Group 2 will NOT receive any nerve blocks.

Ropivacaine DRUG

60 ml 0.2% ropivacaine

Group 1 patients will receive nerve block per standard of care; Group 2 will NOT receive any nerve blocks.

Dex DRUG

10 mg DEX/ 80 mg MPA

Group 2 will NOT receive any nerve blocks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Hospital St Raphael

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Nerve Block; Ropivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Jinlei Li, MD, PhD
• Organization: Yale School of Medicine: Anesthesiology

jinlei.li@yale.edu

(203) 785-2802

Study Officials

• Jinlei Li, MD PhD FASA

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: November 11, 2019
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: September 23, 2022
• Results First Posted: September 23, 2022

Record last verified: 2022-08

Locations

US (1)