Post Surgical PainDex DoseNCT01690663
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
A study testing Bupivacaine 0.25%, Dexamethasone and normal saline in people with Post Surgical Pain, run by University of Pennsylvania at 1 site in United States.
Trial summary
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Surgical Pain
- What is being tested?
- Bupivacaine 0.25%, Dexamethasone and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
- Ability to sign informed consent.
- Ability to follow study protocol, and speak, read and write in English.
- Must have valid phone number for follow-up purpose.
- Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.
Who cannot join
- Patient younger than 18 years old and older than age 70
- Patient refusal to sign consent
- Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
- Allergy to any of the protocol medications
- Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
- Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19139
About this study
Official title: Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.
Read the detailed description
The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.
- Conditions
- Post Surgical Pain
- Being tested
- Bupivacaine 0.25%, Dexamethasone, normal saline
- 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 0.25%Drug
DexamethasoneDrug
normal salineDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0.25% mixed with 1ml normal saline | Placebo comparator | Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Receives: Drug: Bupivacaine 0.25%; Drug: normal saline |
| Bupivacaine 0.25% with 1mg dexamethasone (1ml) | Active comparator | Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Receives: Drug: Bupivacaine 0.25%; Drug: Dexamethasone |
| Bupivacaine 0.25% mixed with 2mg dexamethasone | Active comparator | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Receives: Drug: Bupivacaine 0.25%; Drug: Dexamethasone |
| Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml | Active comparator | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Receives: Drug: Bupivacaine 0.25%; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Variable is Post Operative Sensory Block Duration
This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Measured: days 1, 2, and day 7
Secondary outcomes (1)
The Secondary Outcome Variable is Post Operative Motor Block Duration
This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Measured: days 1, 2, and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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 Surgical PainStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiabin Liu, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690663
- Sponsor's protocol ID
- 815628
- Acronym
- Dex Dose
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2012
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01690663
- Acronym / sponsor ID
- Dex Dose / 815628
- Conditions
- Post Surgical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.
Detailed description
The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0.25% mixed with 1ml normal saline | Placebo comparator | Drug: Bupivacaine 0.25%, Drug: normal salineBupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) |
| Bupivacaine 0.25% with 1mg dexamethasone (1ml) | Active comparator | Drug: Bupivacaine 0.25%, Drug: DexamethasoneBupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) |
| Bupivacaine 0.25% mixed with 2mg dexamethasone | Active comparator | Drug: Bupivacaine 0.25%, Drug: DexamethasoneBupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) |
| Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml | Active comparator | Drug: Bupivacaine 0.25%, Drug: DexamethasoneBupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
- Ability to sign informed consent.
- Ability to follow study protocol, and speak, read and write in English.
- Must have valid phone number for follow-up purpose.
- Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.
Key exclusion criteria (6 listed)
- Patient younger than 18 years old and older than age 70
- Patient refusal to sign consent
- Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
- Allergy to any of the protocol medications
- Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
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 0.25% | Drug | Bupivacaine 0.25% mixed with 1ml normal saline, Bupivacaine 0.25% mixed with 2mg dexamethasone, Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml, Bupivacaine 0.25% with 1mg dexamethasone (1ml) |
| Dexamethasone | Drug | Bupivacaine 0.25% mixed with 2mg dexamethasone, Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml, Bupivacaine 0.25% with 1mg dexamethasone (1ml) |
| normal salineplacebo | Drug | Bupivacaine 0.25% mixed with 1ml normal saline |
Primary outcome
Primary Outcome Variable is Post Operative Sensory Block Duration
Time frame: days 1, 2, and day 7
This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
1 secondary outcome
The Secondary Outcome Variable is Post Operative Motor Block Duration
Time frame: days 1, 2, and day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jiabin Liu, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25%, Dexamethasone and normal saline in people with Post Surgical Pain, run by University of Pennsylvania 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 2017. 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. Some participants in this study may receive a placebo. 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 4 May 2017). 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?
Primary Outcome Variable is Post Operative Sensory Block Duration (time frame: days 1, 2, and day 7). 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 4 May 2017.