Pain and Sensation After Regional Anesthesia - Pilot Study

Completed

• Conditions: Anesthesia, Conduction; Osteoarthritis, Hip

• Registration Number: NCT03623035
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-08-16
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Results First Submitted: 2018-10-08
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-25
• Results First Posted: 2019-06-05
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Pain Score With Activity	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

Name	Time	Method
Patient Pain Scores at Rest	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.
Number of Participants Reporting Pin Prick Sensation	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.

Trial Locations

Locations (1)

Davie Medical Center; 🇺🇸 Bermuda Run, North Carolina, United States