Postoperative PainNCT03261310
Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
A study of Postoperative Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2018
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-90 years old
- undergoing non-emergent craniotomy or single level lumbar laminectomy
- must be able to rate pain on a 0-10 scale post-operatively
Who cannot join
- history of liver disease
- allergy to acetaminophen
- age less than 18 years
- renal failure with creatinine clearance less than 30
- pregnancy
- altered mentation with inability to report pain score
Show all 9Show fewer
- patients who have received acetaminophen within 6 hours of surgery
- patients in which a neuraxial technique has been performed for surgery
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Dimitar Dentchev, MD, 210-916-2118, dimitar.i.dentchev.civ@mail.mil
Dimitar Dentchev, MD
About this study
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
Read the detailed description
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
- Conditions
- Postoperative Pain
- Being tested
- Acetaminophen or Placebo
- Keywords
- acetaminophen, pain, laminectomy, craniotomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen or PlaceboDrug
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen & Craniotomy | Experimental | Drug: Acetaminophen 1000mg administered intravenously during craniotomy Receives: Drug: Acetaminophen or Placebo |
| Placebo & Craniotomy | Placebo comparator | Placebo administered intravenously during craniotomy. Receives: Drug: Acetaminophen or Placebo |
| Acetaminophen & Laminectomy | Experimental | Acetaminophen 1000mg administered intravenously during laminectomy. Receives: Drug: Acetaminophen or Placebo |
| Placebo & Laminectomy | Placebo comparator | Placebo administered during laminectomy. Receives: Drug: Acetaminophen or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).
Measured: 1hour -6 hours
Secondary outcomes (1)
Opioid administration
Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.
Measured: 1 hour-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startMay 2013
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dimitar Dentchev, Brooke Army Medical Center
- Investigators
- Dimitar Dentchev, MD, Principal investigator, BAMCBetsy Murray, MD, Study chair, BAMCRobert Vietor, MD, Study chair, BAMCJonathan Deeth, MD, Study chair, BAMCDaniel Stypula, DO, Study chair, BAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261310
- Sponsor's protocol ID
- 386486-1
- Status last verified
- Aug 2017
- First submitted
- 23 Apr 2014
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
- ClinicalTrials.gov ID
- NCT03261310
- Acronym / sponsor ID
- 386486-1
- Conditions
- Postoperative Pain
- Keywords
- acetaminophen, pain, laminectomy, craniotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- May 2013
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 25 Aug 2017 (actual)
- 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.
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
Detailed description
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen & Craniotomy | Experimental | Drug: Acetaminophen or PlaceboDrug: Acetaminophen 1000mg administered intravenously during craniotomy |
| Placebo & Craniotomy | Placebo comparator | Drug: Acetaminophen or PlaceboPlacebo administered intravenously during craniotomy. |
| Acetaminophen & Laminectomy | Experimental | Drug: Acetaminophen or PlaceboAcetaminophen 1000mg administered intravenously during laminectomy. |
| Placebo & Laminectomy | Placebo comparator | Drug: Acetaminophen or PlaceboPlacebo administered during laminectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-90 years old
- undergoing non-emergent craniotomy or single level lumbar laminectomy
- must be able to rate pain on a 0-10 scale post-operatively
Key exclusion criteria (9 listed)
- history of liver disease
- allergy to acetaminophen
- age less than 18 years
- renal failure with creatinine clearance less than 30
- 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 |
|---|---|---|
| Acetaminophen or PlaceboStudy subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively". | Drug | Acetaminophen & Craniotomy, Acetaminophen & Laminectomy, Placebo & Craniotomy, Placebo & Laminectomy |
Primary outcome
Pain Scores
Time frame: 1hour -6 hours
Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).
1 secondary outcome
Opioid administration
Time frame: 1 hour-6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Dimitar Dentchev, MD principal investigator
BAMC
Betsy Murray, MD study chair
BAMC
Robert Vietor, MD study chair
BAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Postoperative Pain, run by Brooke Army 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 3 inclusion and 9 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 25 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitar Dentchev, MD (210-916-2118, dimitar.i.dentchev.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 1hour -6 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 25 Aug 2017.