Continuous Infusions Vs Scheduled Bolus Infusions

Phase 4

Recruiting

• Conditions: Pain, Postoperative; Surgical Procedure, Unspecified
• Interventions: Drug: Ropivacaine

• Registration Number: NCT03230565
• Lead Sponsor: Stanford University

Brief Summary

To compare continuous infusions to bolus infusions and there affect 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.

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Study Start: 2018-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Infusion	Ropivacaine	Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.
Intermittent Bolus Infusion	Ropivacaine	Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.

Primary Outcome Measures

Name	Time	Method
Post-surgical pain	2-3 days after surgery	Patients will rate their pain on a 0-10 scale

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	2-3 days after surgery	Pain medications consumed by patients will be collected

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States