Health TrialsbyHealthPanel

Effect of Local Anesthetic Concentration on Rebound Pain

ConditionsRebound PainShoulder ArthroplastyInterscalene Block
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Total shoulder replacement patients (anatomic and reverse)

Adult patients (greater than or equal to 18 years)

Any gender

Any race

Disqualifiers

substance/opioid use disorder

complex regional pain syndromes

fibromyalgia

Daily persistent opioid use spanning 3 months prior to surgery date

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine

    Drug

    We are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg).

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: ConcentratedActive comparator 1 intervention
Group B: DiluteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Max NRS Pain Score at 24 hours

Pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

Time frame
24 hours after intervention

Secondary outcomes

1

Qor15 score questionnaire.

Patient will answer QoR15 questionnaire

Time frame
24, 48 and 72 hours.
2

Lowest NRS pain score

Lowest pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

Time frame
24, 48, 72 hours
3

Opioid Use

Total doses used will be converted to Morphine Milligram Equivalents

Time frame
Assessed at 72 hours
4

Sensory Block Duration

The Investigator will ask the patient how long they felt the nerve block was effective, in terms of hours.

Time frame
Assessed at 24 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov
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