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Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study

ConditionsRebound PainShoulder ArthroplastyInterscalene Block
Trial statusNot yet recruiting
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

168 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

Patients will be Assessed 24 hours after intervention for a pain score between 0 and 10, 10 being the worst pain imaginable.

Time frame
24 hours after intervention; will also be assessed at 48 and 72 hours, though these are not the primary outcome for the study.

Secondary outcomes

1

Qor15 score questionnaire.

Patient will answer QoR15 questionnaire

Time frame
24, 48 and 72 hours.
2

Lowest NRS pain score

Patient will be assessed for lowest NRS pain scores

Time frame
24, 48, 72 hours
3

Opioid Use

Total doses used will be converted to MMEs.

Time frame
Assessed at 72 hours
4

Sensory Block Duration

We 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

This trial is not recruiting at the moment. You can still explore other options: