PainNCT02067442
Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy
A study testing oral acetaminophen and intravenous acetaminophen in people with Pain, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- oral acetaminophen and intravenous acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level lumbar micro disk surgery
- Ages 18-65
Who cannot join
- morbid obesity
- prior back surgery
- opioid tolerance
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hopsital
Philadelphia, Pennsylvania, 19107
Marc Fisicaro, MD, marc.fisicaro@jefferson.edu
About this study
Official title: Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy
Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.
- Conditions
- Pain
- Being tested
- oral acetaminophen, intravenous acetaminophen
- Keywords
- acetaminophen intravenous oral pain scores opioids
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral acetaminophenDrug
Also called Tylenol
1000 milligrams given orally before surgery
intravenous acetaminophenDrug
Also called Ofirmev
1000 milligrams of intravenous acetaminophen given before surgery
| Study group | Role | What they receive |
|---|---|---|
| oral acetaminophen | Active comparator | Patients in this arm of the study will receive oral acetaminophen and an IV placebo Receives: Drug: oral acetaminophen |
| intravenous acetaminophen | Active comparator | Patients in this arm of the study will receive IV acetaminophen and an oral placebo Receives: Drug: intravenous acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery.
Measured: Day of surgery
Secondary outcomes (1)
Quantity of intraoperative and postoperative opioids administered.
All doses of opioids given on the day of surgery will be recorded.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067442
- Sponsor's protocol ID
- 12D.685
- Status last verified
- Mar 2015
- First submitted
- 17 Jan 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT02067442
- Acronym / sponsor ID
- 12D.685
- Conditions
- Pain
- Keywords
- acetaminophen intravenous oral pain scores opioids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 20 Feb 2014 (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.
Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral acetaminophen | Active comparator | Drug: oral acetaminophenPatients in this arm of the study will receive oral acetaminophen and an IV placebo |
| intravenous acetaminophen | Active comparator | Drug: intravenous acetaminophenPatients in this arm of the study will receive IV acetaminophen and an oral placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single level lumbar micro disk surgery
- Ages 18-65
Key exclusion criteria (4 listed)
- morbid obesity
- prior back surgery
- opioid tolerance
- pregnancy
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 |
|---|---|---|
| oral acetaminophenAlso: Tylenol1000 milligrams given orally before surgery | Drug | oral acetaminophen |
| intravenous acetaminophenAlso: Ofirmev1000 milligrams of intravenous acetaminophen given before surgery | Drug | intravenous acetaminophen |
Primary outcome
Postoperative pain scores
Time frame: Day of surgery
Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery.
1 secondary outcome
Quantity of intraoperative and postoperative opioids administered.
Time frame: Day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral acetaminophen and intravenous acetaminophen in people with Pain, run by Thomas Jefferson University 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 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: status not confirmed, as of the sponsor's last update on 18 Mar 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc D Fisicaro, MD (215-955-6161, marc.fisicaro@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: Day of surgery). 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 18 Mar 2015.