Continuous Infusions vs Scheduled Bolus Infusions

Pain, Postoperative Clinical Trial

Official title:

A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230565
• Other study ID #: 41434
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: January 16, 2024

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare continuous infusions to bolus infusions and there affect on post-surgical pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgical Procedure, Unspecified

Intervention

Drug:
• Ropivacaine
Patient will be given a continuous infusion of local anesthetic.
• Ropivacaine
Patient will be given a scheduled intermittent bolus of local anesthetic.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-surgical pain	Patients will rate their pain on a 0-10 scale	2-3 days after surgery
Secondary	Opioid Consumption	Pain medications consumed by patients will be collected	2-3 days after surgery