Post Operative PainPhase 4NCT02043704
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
A Phase 4 study testing IV Acetaminophen in people with Post Operative Pain, run by TriHealth Inc. at 1 site in United States.
Trial summary
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2016
- Phase
- Phase 4
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 18 and 70 years
- Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
- Scheduled to undergo major vaginal reconstruction
- Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
Who cannot join
- Allergy to acetaminophen
- Liver disease (chronic or active)
- Chronic alcohol use (>1 drink/day)
- Bleeding diathesis
- Renal disease
- Opiate dependent or daily use
Show all 11Show fewer
- History of chronic pain
- Mental or cognitive disorder preventing patient to accurately verbalize pain levels
- Undergoing abdominal or laparoscopic procedures at the time of surgery
- Allergy to hydromorphone
- Surgery is not performed under general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio, 45220
About this study
Official title: The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
Read the detailed description
see brief summary
- Conditions
- Post Operative Pain
- Being tested
- IV Acetaminophen
- Keywords
- IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Ofirmev
Details covered in arm description.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. Receives: Drug: IV Acetaminophen |
| Saline | Placebo comparator | Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. Receives: Drug: IV Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain While Active - 18 hr
Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.
Measured: 18 hours
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
Measured: 24 hours
Secondary outcomes (10)
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
Measured: 24 hours
Time to First Rescue Narcotic
The time from the end of surgery to the time any IV narcotic is given.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for itching.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for headache.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for insomnia.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for rash/hives.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for shortness of breath.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for respiratory depression.
Measured: 24 hours
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for urinary retention.
Measured: 24 hours
Time to Ambulation
Length of time from the end of surgery to the time of ambulation.
Measured: 1800 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrina Crisp, MD, MSc, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043704
- Sponsor's protocol ID
- 13072
- Status last verified
- Feb 2018
- First submitted
- 21 Jan 2014
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.
PubMed 28230615
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02043704
- Acronym / sponsor ID
- 13072
- Conditions
- Post Operative Pain
- Keywords
- IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 14 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
Detailed description
see brief summary
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV AcetaminophenSubjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. |
| Saline | Placebo comparator | Drug: IV AcetaminophenSubjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women between the ages of 18 and 70 years
- Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
- Scheduled to undergo major vaginal reconstruction
- Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
Key exclusion criteria (11 listed)
- Allergy to acetaminophen
- Liver disease (chronic or active)
- Chronic alcohol use (>1 drink/day)
- Bleeding diathesis
- Renal disease
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 |
|---|---|---|
| IV AcetaminophenAlso: OfirmevDetails covered in arm description. | Drug | IV Acetaminophen, Saline |
Primary outcome
Pain While Active - 18 hr
Time frame: 18 hours
Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Time frame: 24 hours
Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
10 secondary outcomes
Narcotic Associated Side Effects
Time frame: 24 hours
Time to First Rescue Narcotic
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Narcotic Associated Side Effects
Time frame: 24 hours
Time to Ambulation
Time frame: 1800 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28230615Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.
- Individual participant dataSharing planned: No
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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.
Catrina Crisp, MD, MSc principal investigator
TriHealth Inc.
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 IV Acetaminophen in people with Post Operative Pain, run by TriHealth Inc. 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: finished, as of the sponsor's last update on 16 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2018). 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?
Pain While Active - 18 hr (time frame: 18 hours). The study lists 2 primary outcomes in all. 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 NCT02043704, 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 16 Aug 2018.