Post Operative PainPhase 4NCT07349810
Post Operative Infusion Pump Pain Study
A Phase 4 study testing Bupivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution and 1.3% liposomal bupivacaine (Exparel) in people with Post Operative Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution and 1.3% liposomal bupivacaine (Exparel)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 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
- Age 18 years or older
- ACL reconstruction
- Open shoulder labrum or rotator cuff surgery
- Arthroscopic rotator cuff repair
- Proximal or distal patellar realignment surgery
- Open knee arthrotomy cases - Inside out meniscus repair, OCA, MAT
Who cannot join
- Age under 18 years
- Body mass index of greater than 40 kg/m2
- American Society of Anesthesiologist class 4 physical status or greater
- History of drug or alcohol abuse
- Chronic opioid use/pain management doctor
- Allergy to bupivacaine, ropivacaine or pharmacologic analogs
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- Any coagulation disorders
- Existing nerve injury
- Severe bronchopulmonary disease
- Pregnant patients
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
University Center for Ambulatory Surgery
Somerset, New Jersey, 08873
About this study
Official title: Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign.
Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups.
Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution, 1.3% liposomal bupivacaine (Exparel), ambIT Infusion Pump
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% Injectable SolutionDrug
Preoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients
- A bolus of 20cc will be used for saphenous nerve blocks for knee surgeries
- A bolus of 15cc will be used for interscalene nerve blocks for shoulder surgeries
Ropivacaine 0.2% Injectable SolutionDrug
Post-operative continuous infusion
1.3% liposomal bupivacaine (Exparel)Drug
Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)
ambIT Infusion PumpDevice
A pain pump provides intermittent delivery of medication to manage post-surgery pain.
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative: Continuous ropivacaine via Ambit pump | Experimental | Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders). Receives: Drug: Bupivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution; Device: ambIT Infusion Pump |
| Pre-Operative: Liposomal bupivacaine (Exparel) | Active comparator | A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively Receives: Drug: Bupivacaine 0.5% Injectable Solution; Drug: 1.3% liposomal bupivacaine (Exparel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period
Compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. NPRS score difference of approximately 1.5 +/- 1 (approximately 2 points) to detect clinically significant difference in pain score.
Measured: Postoperative days 0, 1,2,3,4,7,10, 14
Secondary outcomes (2)
Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups
use of narcotic and other analgesic pain medication throughout the 14 day postoperative period
Measured: Postoperative period through day 14
Safety Outcomes
Evaluate the rates of catheter site infection, extravasation, pump malfunction
Measured: Postoperative period through day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 4 week time increments across the study recruitment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Gatt, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349810
- Sponsor's protocol ID
- Pro2022000405
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trail, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT07349810
- Acronym / sponsor ID
- Pro2022000405
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign.
Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups.
Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 4 week time increments across the study recruitment period.
| Arm | Type | Receives |
|---|---|---|
| Post-Operative: Continuous ropivacaine via Ambit pump | Experimental | Drug: Bupivacaine 0.5% Injectable Solution, Drug: Ropivacaine 0.2% Injectable Solution, Device: ambIT Infusion PumpPostoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders). |
| Pre-Operative: Liposomal bupivacaine (Exparel) | Active comparator | Drug: Bupivacaine 0.5% Injectable Solution, Drug: 1.3% liposomal bupivacaine (Exparel)A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- ACL reconstruction
- Open shoulder labrum or rotator cuff surgery
- Arthroscopic rotator cuff repair
- Proximal or distal patellar realignment surgery
Key exclusion criteria (10 listed)
- Age under 18 years
- Body mass index of greater than 40 kg/m2
- American Society of Anesthesiologist class 4 physical status or greater
- History of drug or alcohol abuse
- Chronic opioid use/pain management doctor
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 |
|---|---|---|
| Bupivacaine 0.5% Injectable SolutionPreoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients * A bolus of 20cc will be used for saphenous nerve blocks for knee surgeries * A bolus of 15cc will be used for interscalene nerve blocks for shoulder surgeries | Drug | Post-Operative: Continuous ropivacaine via Ambit pump, Pre-Operative: Liposomal bupivacaine (Exparel) |
| Ropivacaine 0.2% Injectable SolutionPost-operative continuous infusion | Drug | Post-Operative: Continuous ropivacaine via Ambit pump |
| 1.3% liposomal bupivacaine (Exparel)Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel) | Drug | Pre-Operative: Liposomal bupivacaine (Exparel) |
| ambIT Infusion PumpA pain pump provides intermittent delivery of medication to manage post-surgery pain. | Device | Post-Operative: Continuous ropivacaine via Ambit pump |
Primary outcome
The effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period
Time frame: Postoperative days 0, 1,2,3,4,7,10, 14
Compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. NPRS score difference of approximately 1.5 +/- 1 (approximately 2 points) to detect clinically significant difference in pain score.
2 secondary outcomes
Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups
Time frame: Postoperative period through day 14
Safety Outcomes
Time frame: Postoperative period through day 14
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trail, after deidentification.
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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.
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 Bupivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution and 1.3% liposomal bupivacaine (Exparel) in people with Post Operative Pain, run by Rutgers, The State University of New Jersey 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 6 inclusion and 10 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 21 Jan 2026. 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 Charles Gatt, MD (732-537-0909, cjgatt85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period (time frame: Postoperative days 0, 1,2,3,4,7,10, 14). 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 21 Jan 2026.