Surgical Procedure, UnspecifiedPhase 4NCT03230565
Continuous Infusions vs Scheduled Bolus Infusions
A Phase 4 study testing Ropivacaine in people with Surgical Procedure, Unspecified and Pain, Postoperative, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Pain, Postoperative
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients presenting for nerve block catheters for post-operative analgesia
- ASA physical status I, II, or III.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Archana Verma
Jean Louis-Horn, MD
About this study
Official title: A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
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.
Read the 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.
- Being tested
- Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Continuous infusion
Patient will be given a continuous infusion of local anesthetic.
RopivacaineDrug
Also called Bolus Infusion
Patient will be given a scheduled intermittent bolus of local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Infusion | Active comparator | Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate. Receives: Drug: Ropivacaine |
| Intermittent Bolus Infusion | Active comparator | Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 0, 1, and 2
Secondary outcomes (5)
Opioid consumption
The amount of opioid analgesics (converted to total morphine milligram equivalents) taken by patients will be recorded.
Measured: Post-operative day 0, 1, and 2
Local anesthetic use
The amount of supplemental local anesthetic boluses self-administered by patients will be recorded (in mL).
Measured: 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.
Measured: 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.
Measured: Post-operative day 1 and 2
Patient satisfaction
Patients will be asked to assess their satisfaction with pain management (Yes/No).
Measured: Post-operative day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Jun 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two groups: 1) Continuous infusion group 2) Bolus infusion group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
- Investigators
- Jean Louis-Horn, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230565
- Sponsor's protocol ID
- 41434
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2017
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
- ClinicalTrials.gov ID
- NCT03230565
- Acronym / sponsor ID
- 41434
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of two groups: 1) Continuous infusion group 2) Bolus infusion group
| Arm | Type | Receives |
|---|---|---|
| Continuous Infusion | Active comparator | Drug: RopivacaineLocal anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate. |
| Intermittent Bolus Infusion | Active comparator | Drug: RopivacaineLocal anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients presenting for nerve block catheters for post-operative analgesia
- ASA physical status I, II, or III.
Key exclusion criteria (7 listed)
- Pregnancy
- Incarceration
- Age <18
- BMI >35
- Pre-operative opioid use >30 mg morphine equivalents per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Continuous infusionPatient will be given a continuous infusion of local anesthetic. | Drug | Continuous Infusion |
| RopivacaineAlso: Bolus InfusionPatient will be given a scheduled intermittent bolus of local anesthetic. | Drug | Intermittent Bolus Infusion |
Primary outcome
Post-surgical pain
Time frame: 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.
5 secondary outcomes
Opioid consumption
Time frame: Post-operative day 0, 1, and 2
Local anesthetic use
Time frame: Post-operative day 1 and 2
Quality of recovery
Time frame: Post-operative day 1 and 2
Evidence of diaphragmatic paralysis
Time frame: Post-operative day 1 and 2
Patient satisfaction
Time frame: Post-operative day 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Louis-Horn, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Surgical Procedure, Unspecified and Pain, Postoperative, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron J Deng, BS (408-914-5494, adeng1@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical pain (time frame: Post-operative day 0, 1, and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.