Pelvic Organ ProlapsePhase 4NCT02155738

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

A Phase 4 study testing IV Acetaminophen and IV normal saline in people with Pelvic Organ Prolapse, run by Halina M Zyczynski, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: IV Acetaminophen and IV normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 1 siteUnited States
Study dates: Jul 2014to 31 Aug 2017
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women ≥ 18 years of age
scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
women anticipated to have a hospital stay ≥24 hours

Who cannot join

allergy/intolerance to acetaminophen
hepatic dysfunction
significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

Trial locations and contacts

1 site in 1 country.

United States1 site

Magee-Womens Hospital of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

Read the detailed description

This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.

Conditions: Pelvic Organ Prolapse
Being tested: IV Acetaminophen, IV normal saline
Keywords: IV acetaminophen, Postoperative pain, Pelvic organ prolapse surgery, Pelvic organ prolapse repair
Medical subject headings: Pelvic Organ Prolapse, 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
IV normal salineDrug
Also called placebo
IV normal saline

Study groups in NCT02155738
Study group	Role	What they receive
Placebo	Placebo comparator	100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. Receives: Drug: IV normal saline
IV Acetaminophen	Experimental	100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. Receives: Drug: IV Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Postoperative Pain
VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.
For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.
The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.
Measured: 24 hours
Cumulative Narcotic Consumption Over the First 24 Hours
Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.
Measured: First 24 hours

Secondary outcomes (1)

Interference of Pain With Physical, Mental and Social Activities
Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.
This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.
A higher PROMIS score indicates more 'hurt' or pain.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201431 Aug 2017

First posted4 Jun 2014 (estimated)
Study startJul 2014
Primary completion31 Aug 2017
Study completion31 Aug 2017

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 Pelvic Organ ProlapseStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02155738
Sponsor's protocol ID: PFD-C-14-009
Status last verified: Oct 2018
First submitted: 29 May 2014
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.
PubMed 30741813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial
ClinicalTrials.gov ID: NCT02155738
Acronym / sponsor ID: PFD-C-14-009
Conditions: Pelvic Organ Prolapse
Keywords: IV acetaminophen, Postoperative pain, Pelvic organ prolapse surgery, Pelvic organ prolapse repair
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Halina M Zyczynski, MDUniversity, hospital or other
Study start: Jul 2014
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 4 Jun 2014 (estimated)
Results: Posted 19 Nov 2018

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 determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: IV normal saline100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
IV Acetaminophen	Experimental	Drug: IV Acetaminophen100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Women ≥ 18 years of age
scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
women anticipated to have a hospital stay ≥24 hours

Key exclusion criteria (3 listed)

allergy/intolerance to acetaminophen
hepatic dysfunction
significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

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: Ofirmev	Drug	IV Acetaminophen
IV normal salineAlso: placeboIV normal saline	Drug	Placebo

Primary outcome

Change From Baseline in Postoperative Pain
Time frame: 24 hours
VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain. For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score. The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.
Cumulative Narcotic Consumption Over the First 24 Hours
Time frame: First 24 hours
Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.

1 secondary outcome

Interference of Pain With Physical, Mental and Social Activities
Time frame: 1 week

Results and safety

Results posted to the registry on 19 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaginal Surgery - Placebo	50	49
Vaginal Surgery - IV Acetaminophen	52	52
Laparoscopic Surgery - Placebo	51	51
Laparoscopic Surgery - IV Acetaminophen	51	50

Primary outcome: Change From Baseline in Postoperative Pain

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Vaginal Surgery - Placebo n = 44	Vaginal Surgery - IV Acetaminophen n = 41	Laparoscopic Surgery - Placebo n = 41	Laparoscopic Surgery - IV Acetaminophen n = 36
Value	20.5 (23.1)	29.2 (28.3)	20.7 (24.6)	20.1 (25.7)

Vaginal Surgery - Placebo vs Vaginal Surgery - IV Acetaminophen vs Laparoscopic Surgery - Placebo vs Laparoscopic Surgery - IV Acetaminophen: p <0.05, Mixed Models Analysis

Population analysed: The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that a 24 hour VAS was not obtained from the subject.

Primary outcome: Cumulative Narcotic Consumption Over the First 24 Hours

Time frame: First 24 hours. Mean (Standard Deviation). Unit: mg

Measure	Vaginal Surgery - Placebo n = 49	Vaginal Surgery - IV Acetaminophen n = 52	Laparoscopic Surgery - Placebo n = 51	Laparoscopic Surgery - IV Acetaminophen n = 50
Value	32.5 (24.7)	31.6 (23.6)	47.4 (24.2)	44.5 (24.2)

Vaginal Surgery - Placebo vs Vaginal Surgery - IV Acetaminophen vs Laparoscopic Surgery - Placebo vs Laparoscopic Surgery - IV Acetaminophen: p <0.05, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected from day of surgery until 6 weeks postop.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaginal Surgery - Placebo	1 of 49 (2%)	0 of 49 (0%)	0 of 49
Vaginal Surgery - IV Acetaminophen	1 of 52 (1.9%)	0 of 52 (0%)	0 of 52
Laparoscopic Surgery - Placebo	0 of 51 (0%)	0 of 51 (0%)	0 of 51
Laparoscopic Surgery - IV Acetaminophen	3 of 50 (6%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30741813Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.

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Active, not recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 and IV normal saline in people with Pelvic Organ Prolapse, run by Halina M Zyczynski, MD 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 3 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 19 Nov 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 19 Nov 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?

Change From Baseline in Postoperative Pain (time frame: 24 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 NCT02155738, 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 19 Nov 2018.