Trial Outcomes & Findings for Pain and Sensation After Regional Anesthesia - Pilot Study (NCT NCT03623035)

NCT ID: NCT03623035

Last Updated: 2019-10-23

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 Hours post block placement
• Results posted on: 2019-10-23

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Lumbar Plexus Block Group n=10 Participants This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=10 Participants
Age, Categorical >=65 years	3 Participants n=10 Participants
Sex: Female, Male Female	9 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: 6 Hours post block placement

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.

Outcome measures

Measure	Lumbar Plexus Block Group n=10 Participants 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	1.4 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6 Hours post block placement

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.

Outcome measures

Measure	Lumbar Plexus Block Group n=10 Participants 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 Scores at Rest	1 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 Hours post block placement

Population: Number of patients who had pin prick sensation at the level of L5/S1 6 hours after nerve block and spinal placement.

Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.

Outcome measures

Measure	Lumbar Plexus Block Group n=10 Participants This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
Number of Participants Reporting Pin Prick Sensation	9 Participants

Adverse Events

Lumbar Plexus Block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Edwards

Wake Forest Baptist Health

Phone: 3367168222

Email: chedward@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place