Post-operative PainNCT03201809
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
A study testing On-Q and Ultrasound guided pectoral nerve block in people with Post-operative Pain, run by University of California, Davis at 1 site in United States.
Trial summary
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- On-Q and Ultrasound guided pectoral nerve block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.
Who cannot join
- pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.
- Conditions
- Post-operative Pain
- Being tested
- On-Q, Ultrasound guided pectoral nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-QDevice
0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
Ultrasound guided pectoral nerve blockDrug
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection
| Study group | Role | What they receive |
|---|---|---|
| On-Q Catheter | Experimental | On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days). Receives: Device: On-Q |
| Ultrasound Guided Pectoral Nerve Block | Active comparator | Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection Receives: Drug: Ultrasound guided pectoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Narcotic Usage
amount of narcotic used
Measured: post operation up to 2 days
Secondary outcomes (2)
Post-operative Anti-emetic Usage
number and amount of anti-emetic used
Measured: post operation up to 2 days
Post-operative Self-reported Pain Scores
Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.
Measured: post operation up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Sep 2016
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Wong, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201809
- Sponsor's protocol ID
- 918749
- Status last verified
- Oct 2021
- First submitted
- 21 Jun 2017
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: available only as aggregate / HIPAA non-identifiable data in published papers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03201809
- Acronym / sponsor ID
- 918749
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
| Arm | Type | Receives |
|---|---|---|
| On-Q Catheter | Experimental | Device: On-QOn-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days). |
| Ultrasound Guided Pectoral Nerve Block | Active comparator | Drug: Ultrasound guided pectoral nerve blockSingle Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.
Key exclusion criteria (1 listed)
- pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
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 |
|---|---|---|
| On-Q0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral | Device | On-Q Catheter |
| Ultrasound guided pectoral nerve blockSingle Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection | Drug | Ultrasound Guided Pectoral Nerve Block |
Primary outcome
Post-operative Narcotic Usage
Time frame: post operation up to 2 days
amount of narcotic used
2 secondary outcomes
Post-operative Anti-emetic Usage
Time frame: post operation up to 2 days
Post-operative Self-reported Pain Scores
Time frame: post operation up to 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. available only as aggregate / HIPAA non-identifiable data in published papers.
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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. This study is not recruiting at the moment.
Michael S Wong, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Q and Ultrasound guided pectoral nerve block in people with Post-operative Pain, run by University of California, Davis 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Oct 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Narcotic Usage (time frame: post operation up to 2 days). 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 15 Oct 2021.