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Completed

NCT Number: NCT03977454

Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale-New Haven Hospital St Raphael

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Nerve Block

Procedure

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)

Procedure

Intraoperatively, the surgeon will perform PAI per standard of care with the medications:

  • 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA

Ropivacaine

Drug

60 ml 0.2% ropivacaine

Dex

Drug

10 mg DEX/ 80 mg MPA

Primary outcomes

  1. Daily Opioid Consumption

    Time frame: Up to 72 hours

    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 outcomes

  1. Change in Pain Intensity While in Hospital

    Time frame: Up to 2 days

    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.

  2. Length of Stay

    Time frame: Up to 5 days

    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.

  3. Harris Hip Score

    Time frame: 2 weeks post operation

    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.

  4. Brief Pain Inventory: Interference

    Time frame: 2 weeks post operation

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2019
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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