Pain and Sensation After Regional Anesthesia - Pilot Study

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623035
• Other study ID #: IRB00052579
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: February 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Conduction
• Osteoarthritis, Hip

Locations

Country	Name	City	State
United States	Davie Medical Center	Bermuda Run	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Hours post block placement
Secondary	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.	6 Hours post block placement
Secondary	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.	6 Hours post block placement