An observational study in Anesthesia, Conduction and Osteoarthritis, Hip, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 10 is below the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Total Hip Arthroplasty surgeries at Davie Medical Center of Wake Forest Baptist Health.
Exclusion Criteria:
This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
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.
Time frame: 6 Hours post block placement
Patient Pain Scores at Rest
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.
Time frame: 6 Hours post block placement
Number of Participants Reporting Pin Prick Sensation
Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.
Time frame: 6 Hours post block placement
| Milestone | Lumbar Plexus Block Group |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| units on a scale | Lumbar Plexus Block Group |
|---|---|
| Patient Pain Score With Activity | 1.4 ± 1.5 |
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.
| units on a scale | Lumbar Plexus Block Group |
|---|---|
| Patient Pain Scores at Rest | 1 ± 1.1 |
Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.
| Participants | Lumbar Plexus Block Group |
|---|---|
| Number of Participants Reporting Pin Prick Sensation | 9 |
Collected over Adverse event data were collected for 30 days after the day of surgery for each patient.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumbar Plexus Block Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Lumbar Plexus Block Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Lumbar Plexus Block Group |
|---|---|
| Female | 9 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | Lumbar Plexus Block Group |
|---|
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Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences