Pain, Postoperative, Surgical Procedure, Unspecified
Conditions
Brief summary
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
DRUGRopivacaine
Patient will be given a continuous infusion of local anesthetic.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
Intervention model description
Comparison of two groups: 1) Continuous infusion group 2) Bolus infusion group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical pain | Post-operative day 0, 1, and 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Post-operative day 0, 1, and 2 | The amount of opioid analgesics (converted to total morphine milligram equivalents) taken by patients will be recorded. |
| Local anesthetic use | Post-operative day 1 and 2 | The amount of supplemental local anesthetic boluses self-administered by patients will be recorded (in mL). |
| Quality of recovery | Post-operative day 1 and 2 | 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. |
| Evidence of diaphragmatic paralysis | Post-operative day 1 and 2 | 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. |
| Patient satisfaction | Post-operative day 1 and 2 | Patients will be asked to assess their satisfaction with pain management (Yes/No). |
Countries
United States
Contacts
Primary ContactAaron J Deng, BS
Outcome results
None listed