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NCT Number: NCT03623035

Pain and Sensation After Regional Anesthesia - Pilot Study

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.

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Key information

Conditions

Anesthesia, Conduction Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Davie Medical Center

Bermuda Run, North Carolina, 27006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Pilot Study on Pain and Sensation After Regional Anesthesia for Total Hip Arthroplasty

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Oct 23, 2019

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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