Clinical trial NCT03623035: Pain and Sensation After Regional Anesthesia - Pilot Study
Official title: Pilot Study on Pain and Sensation After Regional Anesthesia for Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Conduction
Osteoarthritis, Hip
Keywords: Lumbar Plexus block
total hip arthroplasty
Arthroplasty, direct anterior approach
Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Total Hip Arthroplasty surgeries at Davie Medical Center of Wake Forest Baptist Health.

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.

Eligibility 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.

Primary outcomes:
measure: Patient Pain Score With Activity
timeFrame: 6 Hours post block placement
Secondary outcomes:
measure: Patient Pain Scores at Rest
timeFrame: 6 Hours post block placement
measure: Number of Participants Reporting Pin Prick Sensation
timeFrame: 6 Hours post block placement
Other outcomes:
Locations:
city: Bermuda Run
country: United States
facility: Davie Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christopher J Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zhao HY, Kang PD, Xia YY, Shi XJ, Nie Y, Pei FX. Comparison of Early Functional Recovery After Total Hip Arthroplasty Using a Direct Anterior or Posterolateral Approach: A Randomized Controlled Trial. J Arthroplasty. 2017 Nov;32(11):3421-3428. doi: 10.1016/j.arth.2017.05.056. Epub 2017 Jun 8.
citation: Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.
citation: Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595.
citation: Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.