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Pain and Sensation After Regional Anesthesia - Pilot Study

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ClinicalTrials.gov Identifier: NCT03623035
Recruitment Status : Completed
First Posted : August 9, 2018
Results First Posted : June 5, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease
Anesthesia, Conduction Osteoarthritis, Hip

Detailed Description:
The Quadratus Lumborum block (QLB) is a newer regional analgesic technique that may be as effective as Lumbar Plexus blocks (LPB) at providing pain control following direct anterior approach (DAA) hip arthroplasty. The purpose of this study is to collect pilot data to help the design of a future randomized study, comparing a QLB to a LPB for DAA procedures. The investigators will assess for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. This will help determine if pain scores collected at 6hrs reflect analgesia provided by the preoperative LPB alone or if the data is confounded by the presence of spinal anesthesia. This data will help us determine if 6hrs is a feasible primary endpoint to assess pain scores. Additionally, assuming that spinal regression is complete by 6hrs, the VAS pain scores obtained will then be used to perform a power analysis to determine the necessary study size when comparing QLB to LPB for DAA hip arthroplasty.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study on Pain and Sensation After Regional Anesthesia for Total Hip Arthroplasty
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Patient Pain Score With Activity [ Time Frame: 6 Hours post block placement ]
    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.


Secondary Outcome Measures :
  1. Patient Pain Scores at Rest [ Time Frame: 6 Hours post block placement ]
    Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes.

  2. Number of Participants Reporting Pin Prick Sensation [ Time Frame: 6 Hours post block placement ]
    Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Total Hip Arthroplasty surgeries at Davie Medical Center of Wake Forest Baptist Health.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623035


Locations
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United States, North Carolina
Davie Medical Center
Bermuda Run, North Carolina, United States, 27006
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Christopher J Edwards, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol  [PDF] July 30, 2018
No Statistical Analysis Plan (SAP) exists for this study.


Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03623035     History of Changes
Other Study ID Numbers: IRB00052579
First Posted: August 9, 2018    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: October 23, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Lumbar Plexus block
total hip arthroplasty
Arthroplasty, direct anterior approach
Pain
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs