Clinical trial
A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
Name
41434
Description
To compare continuous infusions to bolus infusions and there affect on post-surgical pain.
Trial arms
Trial start
2018-06-01
Estimated PCD
2024-01-16
Trial end
2024-01-16
Status
Completed
Phase
Early phase I
Treatment
Ropivacaine
Patient will be given a continuous infusion of local anesthetic.
Arms:
Continuous Infusion
Other names:
Continuous infusion
Ropivacaine
Patient will be given a scheduled intermittent bolus of local anesthetic.
Arms:
Intermittent Bolus Infusion
Other names:
Bolus Infusion
Size
123
Primary endpoint
Post-surgical pain
2-3 days after surgery
Eligibility criteria
Inclusion Criteria: Enrollment will be offered to adult patients with ASA physical status I, II, or III, presenting for nerve block catheters for post-operative analgesia.
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Exclusion Criteria: Exclusion criteria will include: pregnancy, incarceration, age \<18, BMI \>35, pre-operative opioid use \>30 mg morphine equivalents per day, inability to communicate with investigators by telephone, and pre-existing neuropathy of the operative extremity.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison of two groups: 1) Continuous infusion group 2) Bolus Infusion group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 123, 'type': 'ACTUAL'}}
Updated at
2024-01-26
1 organization
1 product
4 indications
Organization
Stanford UniversityProduct
RopivacaineIndication
Surgical ProcedureIndication
UnspecifiedIndication
PainIndication
Postoperative