ObesityNCT01527942
Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients
A study testing Acetaminophen in people with Obesity and Pain, run by Trinity Health Of New England at 1 site in United States.
Trial summary
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- What is being tested?
- Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbidly Obese and body mass index (BMI) of 35
- Between ages 20-17
- Candidates for Laparoscopic Bariatric Surgery
Who cannot join
- know hypersensitivity to acetaminophen or opioids
- impairment in liver function
- renal dysfunction
- mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
- Being tested
- Acetaminophen, Placebo
- Keywords
- Pain Management
- Medical subject headings
- Obesity, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called OFIRMEV
Intravenous Acetaminophen 1,000 mg IV
PlaceboDrug
Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Active Drug | Experimental | Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Receives: Drug: Acetaminophen |
| Arm 2 - Placebo | Placebo comparator | Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)
Measured: baseline and 24 hours
Secondary outcomes (2)
Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours
The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)
Measured: baseline and 24 hours
Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.
The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.
Measured: 24 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Study Terminated per Principal Investigator's request
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 ObesityStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioannis Raftopoulos, MD, Principal investigator, Saint Francis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527942
- Sponsor's protocol ID
- 12-01-003
- Status last verified
- Mar 2014
- First submitted
- 2 Feb 2012
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01527942
- Acronym / sponsor ID
- 12-01-003
- Keywords
- Pain Management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Terminated per Principal Investigator's request
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Active Drug | Experimental | Drug: AcetaminophenPreoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. |
| Arm 2 - Placebo | Placebo comparator | Drug: PlaceboPreoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Morbidly Obese and body mass index (BMI) of 35
- Between ages 20-17
- Candidates for Laparoscopic Bariatric Surgery
Key exclusion criteria (4 listed)
- know hypersensitivity to acetaminophen or opioids
- impairment in liver function
- renal dysfunction
- mental retardation
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 |
|---|---|---|
| AcetaminophenAlso: OFIRMEVIntravenous Acetaminophen 1,000 mg IV | Drug | Arm 1 - Active Drug |
| PlaceboPlacebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl) | Drug | Arm 2 - Placebo |
Primary outcome
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
Time frame: baseline and 24 hours
The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)
2 secondary outcomes
Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours
Time frame: baseline and 24 hours
Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.
Time frame: 24 hours after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- 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.
Ioannis Raftopoulos, MD principal investigator
Saint Francis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen in people with Obesity and Pain, run by Trinity Health Of New England 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 3 inclusion and 4 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 17 Dec 2015. 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 17 Dec 2015). 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?
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours (time frame: baseline and 24 hours). 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 17 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.