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Pain and Sensation After Regional Anesthesia - Pilot Study

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ClinicalTrials.gov Identifier: NCT03623035
Recruitment Status : Completed
First Posted : August 9, 2018
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Anesthesia, Conduction
Osteoarthritis, Hip
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
9
  90.0%
Male
1
  10.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Patient Pain Score With Activity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description:
This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (1.5)
2.Secondary Outcome
Title Patient Pain Scores at Rest
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description:
This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (1.1)
3.Secondary Outcome
Title Number of Participants Reporting Pin Prick Sensation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who had pin prick sensation at the level of L5/S1 6 hours after nerve block and spinal placement.
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description:
This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
Time Frame Adverse event data were collected for 30 days after the day of surgery for each patient.
Adverse Event Reporting Description No patients experienced adverse events.
 
Arm/Group Title Lumbar Plexus Block Group
Hide Arm/Group Description This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
All-Cause Mortality
Lumbar Plexus Block Group
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lumbar Plexus Block Group
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lumbar Plexus Block Group
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Edwards
Organization: Wake Forest Baptist Health
Phone: 3367168222
EMail: chedward@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03623035     History of Changes
Other Study ID Numbers: IRB00052579
First Submitted: August 6, 2018
First Posted: August 9, 2018
Results First Submitted: October 8, 2018
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019