Postoperative PainPhase 4CadenceNCT01231191
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures
A Phase 4 study testing Intravenous acetaminophen in people with Postoperative Pain and Intraoperative and Postoperative Opioid Requirements, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Intraoperative and Postoperative Opioid Requirements
- What is being tested?
- Intravenous acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing ambulatory surgery under general anesthesia
- Expected postoperative pain to be mild-moderate
- Age 18 years or older
- Have an ASA physical status or 1, 2, or 3
Who cannot join
- Anticipated peripheral or neuraxial nerve block
- Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
- Current chronic opioid or tramadol use
- History of alcohol or opioid abuse
- Known allergy to the study medications
- Pregnancy
Show all 11Show fewer
- Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
- Treated with any acetaminophen-containing medication in the previous 8 hours
- Treated with MAO inhibitors within 10 days prior to surgery
- Inability to communicate with the investigators and hospital staff
- Known or impaired liver function
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Center (Hillcrest and Thornton)
San Diego, California, 92103
About this study
This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.
Read the detailed description
Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
- Being tested
- Intravenous acetaminophen, Intravenous placebo
- 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 acetaminophenDrug
Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
Intravenous placeboDrug
Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Active comparator | Intraoperative IV acetaminophen administered Receives: Drug: Intravenous acetaminophen |
| IV Placebo | Placebo comparator | Intraoperative IV normal saline administered Receives: Drug: Intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge.
Measured: Day of Surgery
Secondary outcomes (9)
A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.
Measured: Day of Surgery
A secondary outcome for this investigation will be the total dose of morphine administered to the patient.
Measured: Day of Surgery
A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.
Measured: Day of Surgery
A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.
Measured: Day of Surgery
A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.
Measured: Day of Surgery
A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.
Measured: Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the study treatments?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.
Measured: Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the level of pain relief from study medication?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.
Measured: Day of Surgery
Adverse events
Measured: Up to one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
Why it stopped: study not funded
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Cadence Pharmaceuticals
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231191
- Sponsor's protocol ID
- IV Acetaminophen
- Acronym
- Cadence
- Status last verified
- Mar 2012
- First submitted
- 27 Oct 2010
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures
- ClinicalTrials.gov ID
- NCT01231191
- Acronym / sponsor ID
- Cadence / IV Acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Cadence Pharmaceuticals
- First posted
- 1 Nov 2010 (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.
This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.
Detailed description
Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Active comparator | Drug: Intravenous acetaminophenIntraoperative IV acetaminophen administered |
| IV Placebo | Placebo comparator | Drug: Intravenous placeboIntraoperative IV normal saline administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing ambulatory surgery under general anesthesia
- Expected postoperative pain to be mild-moderate
- Age 18 years or older
- Have an ASA physical status or 1, 2, or 3
Key exclusion criteria (11 listed)
- Anticipated peripheral or neuraxial nerve block
- Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
- Current chronic opioid or tramadol use
- History of alcohol or opioid abuse
- Known allergy to the study medications
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 acetaminophenAcetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively. | Drug | IV Acetaminophen |
| Intravenous placeboNormal saline administered over 15 minutes intravenously as soon as feasible intraoperatively. | Drug | IV Placebo |
Primary outcome
The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge.
Time frame: Day of Surgery
9 secondary outcomes
A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.
Time frame: Day of Surgery
A secondary outcome for this investigation will be the total dose of morphine administered to the patient.
Time frame: Day of Surgery
A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.
Time frame: Day of Surgery
A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.
Time frame: Day of Surgery
A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.
Time frame: Day of Surgery
A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.
Time frame: Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the study treatments?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.
Time frame: Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the level of pain relief from study medication?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.
Time frame: Day of Surgery
Adverse events
Time frame: Up to one year postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous acetaminophen in people with Postoperative Pain and Intraoperative and Postoperative Opioid Requirements, run by University of California, San Diego 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 8 Mar 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge. (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 8 Mar 2012.