NCT03623035

Brief Summary

This study aims to determine spinal resolution and pain levels after the placement of a lumbar plexus block (LPB) and spinal for total hip replacement procedure. This is a pilot study that looks to collect information in order to design a larger, more significant study comparing Quadratus Lumborum blocks (QLB) and Lumbar Plexus blocks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 5, 2019

Completed
Last Updated

October 23, 2019

Status Verified

February 1, 2019

Enrollment Period

25 days

First QC Date

August 6, 2018

Results QC Date

October 8, 2018

Last Update Submit

October 21, 2019

Conditions

Anesthesia, ConductionOsteoarthritis, Hip

Keywords

Lumbar Plexus blocktotal hip arthroplastyArthroplasty, direct anterior approachPain

Outcome Measures

Primary Outcomes (1)

  • Patient Pain Score With Activity

    Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.

    6 Hours post block placement

Secondary Outcomes (2)

  • Patient Pain Scores at Rest

    6 Hours post block placement

  • Number of Participants Reporting Pin Prick Sensation

    6 Hours post block placement

Study Arms (1)

Lumbar Plexus block Group

This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Total Hip Arthroplasty surgeries at Davie Medical Center of Wake Forest Baptist Health.

You may qualify if:

  • Patients that have elective total hip arthroplasty with DAA at Davie Medical Center.

You may not qualify if:

  • Patients will be excluded if they do not receive a lumbar plexus block and spinal anesthesia.
  • and/or if they have peripheral neuropathy affecting their feet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davie Medical Center

Bermuda Run, North Carolina, 27006, United States

Location

Related Publications (5)

  • Laupacis A, Bourne R, Rorabeck C, Feeny D, Wong C, Tugwell P, Leslie K, Bullas R. The effect of elective total hip replacement on health-related quality of life. J Bone Joint Surg Am. 1993 Nov;75(11):1619-26. doi: 10.2106/00004623-199311000-00006.

    PMID: 8245054BACKGROUND

  • Zhao HY, Kang PD, Xia YY, Shi XJ, Nie Y, Pei FX. Comparison of Early Functional Recovery After Total Hip Arthroplasty Using a Direct Anterior or Posterolateral Approach: A Randomized Controlled Trial. J Arthroplasty. 2017 Nov;32(11):3421-3428. doi: 10.1016/j.arth.2017.05.056. Epub 2017 Jun 8.

    PMID: 28662957BACKGROUND

  • Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.

    PMID: 12032037BACKGROUND

  • Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595.

    PMID: 25157041BACKGROUND

  • Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.

    PMID: 15108988BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, HipPain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christopher Edwards
Organization
Wake Forest Baptist Health
chedward@wakehealth.edu
3367168222

Study Officials

  • Christopher J Edwards, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

August 16, 2018

Primary Completion

September 10, 2018

Study Completion

September 10, 2018

Last Updated

October 23, 2019

Results First Posted

June 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)