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

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.

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: 2025-07
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-28
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

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	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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States