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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Infusion | Active Comparator | Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate. |
|
| Intermittent Bolus Infusion | Active Comparator | Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Patient will be given a continuous infusion of local anesthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical pain | Pain scores will be collected using a Numeric Rating Scale (NRS) from 0-10, where 0 is the lowest and 10 is the highest pain level. | Post-operative day 0, 1, and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | The amount of opioid analgesics (converted to total morphine milligram equivalents) taken by patients will be recorded. | Post-operative day 0, 1, and 2 |
| Local anesthetic use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron J Deng, BS | Contact | 408-914-5494 | adeng1@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jean Louis-Horn, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Comparison of two groups: 1) Continuous infusion group 2) Bolus infusion group
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Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
| Ropivacaine | Drug | Patient will be given a scheduled intermittent bolus of local anesthetic. |
|
|
The amount of supplemental local anesthetic boluses self-administered by patients will be recorded (in mL).
| Post-operative day 1 and 2 |
| Quality of recovery | Quality of recovery will be assessed using a Quality of Recovery (QoR-15) questionnaire. The QoR15 scores range from 0 to 150, where 0 is poor recovery and 150 is excellent recovery. | Post-operative day 1 and 2 |
| Evidence of diaphragmatic paralysis | Ability to breathe will be assessed as a part of QoR-15 questionnaire on 11-point scale, where 0 is never being able to breathe easily and 10 is always being able to breathe easily. | Post-operative day 1 and 2 |
| Patient satisfaction | Patients will be asked to assess their satisfaction with pain management (Yes/No). | Post-operative day 1 and 2 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |