Pain and Sensation After Regional Anesthesia - Pilot Study

NCT ID: NCT03623035

Last Updated: 2019-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2018-09-10

Brief Summary

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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

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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.

Conditions

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Anesthesia, Conduction Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher J Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Davie Medical Center

Bermuda Run, North Carolina, United States

Site Status

Countries

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United States

References

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Laupacis A, Bourne R, Rorabeck C, Feeny D, Wong C, Tugwell P, Leslie K, Bullas R. The effect of elective total hip replacement on health-related quality of life. J Bone Joint Surg Am. 1993 Nov;75(11):1619-26. doi: 10.2106/00004623-199311000-00006.

Reference Type BACKGROUND
PMID: 8245054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28662957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12032037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25157041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15108988 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IRB00052579

Identifier Type: -

Identifier Source: org_study_id

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