Postoperative PainPhase 3NCT01297829
Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
A Phase 3 study testing Intravenous Ibuprofen in people with Postoperative Pain, run by St. Barnabas Medical Center at 1 site in United States.
Trial summary
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intravenous Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary inguinal and/or umbilical hernia repair
- age > 18 years old
Who cannot join
- history of gastrointestinal bleeding
- allergy to ibuprofen
- creatinine > 1.5 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
About this study
Official title: Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.
The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.
- Conditions
- Postoperative Pain
- Being tested
- Intravenous Ibuprofen, IV Placebo
- Keywords
- ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous IbuprofenDrug
Also called Caldolor
800 mg IV ibuprofen 30 minutes preoperatively
IV PlaceboOther
IV normal saline
| Study group | Role | What they receive |
|---|---|---|
| IV Caldolor | Active comparator | Not described Receives: Drug: Intravenous Ibuprofen |
| Placebo | Placebo comparator | Not described Receives: Other: IV Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Narcotic Use
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
Measured: 7 days
Secondary outcomes (1)
Postoperative Visual Analog Pain Scale
The patient will receive a Visual Analog Pain Scale to complete 2 hrs post-operatively, post-operative day 1, post-operative day 3 and post-operative day 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2013
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Barnabas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Responsible party
- Principal investigator, Ronald S. Chamberlain, St. Barnabas Medical Center
- Investigators
- Ronald S Chamberlain, MD, MPA, FACS, Principal investigator, St. Barnabas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297829
- Sponsor's protocol ID
- 2010-11-15
- Status last verified
- Dec 2014
- First submitted
- 15 Nov 2010
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial
- ClinicalTrials.gov ID
- NCT01297829
- Acronym / sponsor ID
- 2010-11-15
- Conditions
- Postoperative Pain
- Keywords
- ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- St. Barnabas Medical CenterUniversity, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 17 Feb 2011 (estimated)
- 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.
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.
The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Caldolor | Active comparator | Drug: Intravenous Ibuprofen |
| Placebo | Placebo comparator | Other: IV Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary inguinal and/or umbilical hernia repair
- age > 18 years old
Key exclusion criteria (3 listed)
- history of gastrointestinal bleeding
- allergy to ibuprofen
- creatinine > 1.5 mg/dL
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 |
|---|---|---|
| Intravenous IbuprofenAlso: Caldolor800 mg IV ibuprofen 30 minutes preoperatively | Drug | IV Caldolor |
| IV PlaceboIV normal saline | Other | Placebo |
Primary outcome
Postoperative Narcotic Use
Time frame: 7 days
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
1 secondary outcome
Postoperative Visual Analog Pain Scale
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Ronald S Chamberlain, MD, MPA, FACS principal investigator
St. Barnabas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Ibuprofen in people with Postoperative Pain, run by St. Barnabas Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 16 Dec 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative Narcotic Use (time frame: 7 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 16 Dec 2014.