NCT02493621

Brief Summary

The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

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

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

July 2, 2015

Results QC Date

June 4, 2018

Last Update Submit

December 19, 2018

Conditions

Keywords

Pain, PostoperativeNerve BlockAnesthesia, Epidural

Outcome Measures

Primary Outcomes (1)

  • Opiate Consumption

    Cumulative opiate consumption in intravenous (IV) morphine mg equivalents (MME)

    48 hours postoperative

Secondary Outcomes (1)

  • Time of First Ambulation

    48 hours

Study Arms (2)

Lumbar plexus

Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.

Lumbar Epidural

Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.

Eligibility Criteria

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

The study team will identify subject by the Primary Diagnosis of THA, (identified by CPT code 27130) and 2) either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449) with the administration of multimodal medication.

You may qualify if:

  • years and older
  • Diagnosis of:
  • Primary THA, (identified by CPT code 27130)
  • Either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449)
  • Perioperative multimodal medication
  • Hospitalized from July 1, 2012 to December 17, 2014.

You may not qualify if:

  • THA Revision
  • ICU admission postoperatively
  • History of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Sylvia Wilson
Organization
MUSC

Study Officials

  • Sylvia Wilson, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 9, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

March 22, 2019

Results First Posted

March 22, 2019

Record last verified: 2018-06

Locations