Continuous Infusions vs Scheduled Bolus Infusions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine, Ropivacaine.
- Who it may be relevant to
- Registry conditions: Surgical Procedure, Unspecified, Pain, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
Overview
The goal of the study is to compare continuous infusions and scheduled bolus infusions for peripheral nerve blocks and their effect on post-surgical pain.
Detailed description
Regional anesthetic techniques are an integral part to many anesthetic approaches, providing both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia peripheral nerve blocks have been shown to reduce postoperative pain and improve measures such as opioid requirements and readiness for discharge. By using a catheter technique for continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2 and 3, further extending these benefits. Historically these catheters have implemented a continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many institutions have implemented this new protocol for catheter dosing. The beneficial effect of scheduled bolus dosing has not been studied in all blocks and all surgical procedures.
The study will consist of three independent arms, each designed to evaluate a different nerve block site: interscalene, adductor canal, and infraclavicular. A total of 60 patients will be enrolled in each arm.
Interventions
- Drug Ropivacaine
Patient will be given a continuous infusion of local anesthetic. - Drug Ropivacaine
Patient will be given a scheduled intermittent bolus of local anesthetic.
Primary outcome measures
- Post-surgical pain [Time frame: Post-operative day 0, 1, and 2]
Secondary outcome measures (5)
- Opioid consumption [Time frame: Post-operative day 0, 1, and 2]
- Local anesthetic use [Time frame: Post-operative day 1 and 2]
- Quality of recovery [Time frame: Post-operative day 1 and 2]
- Evidence of diaphragmatic paralysis [Time frame: Post-operative day 1 and 2]
- Patient satisfaction [Time frame: Post-operative day 1 and 2]
Eligibility criteria
Inclusion criteria
- Adult patients presenting for nerve block catheters for post-operative analgesia
- ASA physical status I, II, or III.
Exclusion criteria
- Pregnancy
- Incarceration
- Age <18
- BMI >35
- Pre-operative opioid use >30 mg morphine equivalents per day
- Inability to communicate with investigators by telephone
- Pre-existing neuropathy of the operative extremity.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT03230565 · 41434