Post-operative PainNCT03391284
Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery
A study testing acetominophen and Acetaminophen in people with Post-operative Pain, run by Scripps Health at 2 sites in United States.
Trial summary
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- acetominophen and 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
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Feb 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older scheduled to undergo robotic-assisted laparoscopic hysterectomy for benign conditions.
Who cannot join
- Known or suspected malignancy,
- Active liver/renal disease,
- Chronic alcohol use/alcoholism,
- Allergy to acetaminophen,
- Conversion to laparotomy,
- hx gastroparesis,
Show all 9Show fewer
- Poorly controlled insulin dependent diabetes or gastric bypass surgery,
- Regular/recent (past 6 months) narcotic use,
- Inability to swallow pills.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Scripps Clinic
San Diego, California, 92130
Scripps Clininc Dept of Ob/Gyn
San Diego, California, 92130
About this study
Official title: Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Primary outcome:
Read more
- Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
- Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
- Difference in postoperative analgesic use between groups
- Narcotics, NSAIDs
- Difference in postoperative N/V between groups
- Patient rated measure - none, mild, moderate, severe
- Cost comparison between drugs
Read the detailed description
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.
Primary outcome:
- Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
- Mean VAS scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
- Difference in postoperative analgesic use between groups - Narcotics, NSAIDs
- Difference in postoperative N/V between groups
- Patient rated measure - none, mild, moderate, severe
- Cost comparison between drugs
Methods:
Patients scheduled to undergo minimally invasive benign gynecologic surgery will be randomized to one of two groups:
Group 1: acetaminophen 1 gram PO 30min before surgery, then saline placebo IV after anesthesia induction but before skin incision
Group 2: receives placebo pill PO 30min before surgery, then acetaminophen 1 gram IV after anesthesia induction but before skin incision
Primary outcome: After surgery, postoperative pain measured at various time points by blinded investigator
2 hours postop, 4 hours postop, 24 hours postop
Secondary outcomes:
- Evaluate N/V - self-rated as none, mild, moderate, severe
- Document amount of analgesic use (narcotic, NSAIDs) during hospital course
- Compute cost comparison between medications
Demographics to collect:
Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length
- Conditions
- Post-operative Pain
- Being tested
- acetominophen, Acetaminophen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetominophenDrug
Also called Ofirmev
INTRAVENOUS
AcetaminophenDrug
Also called Tylenol
ORAL
| Study group | Role | What they receive |
|---|---|---|
| Oral Acetominophen Arm | Experimental | 1000 mg acetominophen oral Receives: Drug: acetominophen; Drug: Acetaminophen |
| Intravenous | Active comparator | 1000 mg acetominophen intravenous Receives: Drug: acetominophen; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - VAS
Pain level 2 hours post treatment
Measured: 2 hours
Secondary outcomes (2)
Pain - VAS
Pain level 4 hours post treatment
Measured: 4 hours
Pain - VAS
Pain level 24 hours post treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Kahn, Scripps Health
- Investigators
- Bruce Kahn, MD, Principal investigator, Scripps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391284
- Sponsor's protocol ID
- SCRIPPS-WHR-ACET-01
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2016
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lombardi TM, Kahn BS, Tsai LJ, Waalen JM, Wachi N. Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1293-1297. doi: 10.1097/AOG.0000000000003578.
PubMed 31764741
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03391284
- Acronym / sponsor ID
- SCRIPPS-WHR-ACET-01
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Jan 2018 (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.
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Primary outcome:
- Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
- Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
- Difference in postoperative analgesic use between groups
- Narcotics, NSAIDs
- Difference in postoperative N/V between groups
- Patient rated measure - none, mild, moderate, severe
- Cost comparison between drugs
Detailed description
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.
Primary outcome:
- Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
- Mean VAS scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
- Difference in postoperative analgesic use between groups - Narcotics, NSAIDs
- Difference in postoperative N/V between groups
- Patient rated measure - none, mild, moderate, severe
- Cost comparison between drugs
Methods:
Patients scheduled to undergo minimally invasive benign gynecologic surgery will be randomized to one of two groups:
Group 1: acetaminophen 1 gram PO 30min before surgery, then saline placebo IV after anesthesia induction but before skin incision
Group 2: receives placebo pill PO 30min before surgery, then acetaminophen 1 gram IV after anesthesia induction but before skin incision
Primary outcome: After surgery, postoperative pain measured at various time points by blinded investigator
2 hours postop, 4 hours postop, 24 hours postop
Secondary outcomes:
- Evaluate N/V - self-rated as none, mild, moderate, severe
- Document amount of analgesic use (narcotic, NSAIDs) during hospital course
- Compute cost comparison between medications
Demographics to collect:
Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Acetominophen Arm | Experimental | Drug: acetominophen, Drug: Acetaminophen1000 mg acetominophen oral |
| Intravenous | Active comparator | Drug: acetominophen, Drug: Acetaminophen1000 mg acetominophen intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older scheduled to undergo robotic-assisted laparoscopic hysterectomy for benign conditions.
Key exclusion criteria (9 listed)
- Known or suspected malignancy,
- Active liver/renal disease,
- Chronic alcohol use/alcoholism,
- Allergy to acetaminophen,
- Conversion to laparotomy,
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 |
|---|---|---|
| acetominophenAlso: OfirmevINTRAVENOUS | Drug | Intravenous, Oral Acetominophen Arm |
| AcetaminophenAlso: TylenolORAL | Drug | Intravenous, Oral Acetominophen Arm |
Primary outcome
Pain - VAS
Time frame: 2 hours
Pain level 2 hours post treatment
2 secondary outcomes
Pain - VAS
Time frame: 4 hours
Pain - VAS
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 31764741Lombardi TM, Kahn BS, Tsai LJ, Waalen JM, Wachi N. Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1293-1297. doi: 10.1097/AOG.0000000000003578.
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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.
Bruce Kahn, MD principal investigator
Scripps
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetominophen and Acetaminophen in people with Post-operative Pain, run by Scripps Health at 2 sites 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 1 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: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain - VAS (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391284, which also lists 1 linked publication.
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 22 Nov 2022.