Opioid UsePhase 4NCT03732469
Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization
A Phase 4 study testing Acetaminophen, Fentanyl and Propofol in people with Opioid Use, run by University of South Florida at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients. Read more about this study
- Who is it for?
- Ages 18 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Acetaminophen, Fentanyl and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Mar 2021
- 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 to 56 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture
Who cannot join
- Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
- Patient with BMI greater than 40
- Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
- Patients with documented allergic reaction to acetaminophen
- Patient with contra-indication to the use of acetaminophen (liver disease)
- Patients with a history of past or current alcohol, drug or opioid abuse
- Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients
The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.
Read the detailed description
As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.
- Conditions
- Opioid Use
- Being tested
- Acetaminophen, Fentanyl, Propofol
- Keywords
- egg retrieval, oocyte retrieval, opioid dependence, rectal acetaminophen, rectal tylenol, pain, opioid use, opioid abuse
- Medical subject headings
- Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.
FentanylDrug
Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital
PropofolDrug
Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl/propofol + acetaminophen | Experimental | In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval. Receives: Drug: Acetaminophen; Drug: Fentanyl; Drug: Propofol |
| Fentanyl/propofol only | Active comparator | Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol. Receives: Drug: Fentanyl; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized
The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome.
Measured: 72 hours following oocyte retrieval
Secondary outcomes (4)
Pain score in post-anesthesia care unit using the Visual Analog Scale
The Visual Analog Scale will be used to assess postoperative pain 1-hour after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.
Measured: 1-hour after oocyte retrieval
24-hour pain score using the Visual Analog Scale
The Visual Analog Scale will be used to assess pain 24 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.
Measured: 24 hours after oocyte retrieval
48-hour pain score using the Visual Analog Scale measuring pain
The Visual Analog Scale will be used to assess pain 48 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.
Measured: 48 hours after oocyte retrieval
72-hour pain score using the Visual Analog Scale measuring pain
The Visual Analog Scale will be used to assess pain 72 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.
Measured: 72 hours after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Nov 2019
- Primary completion31 Dec 2020
- Study completion1 Mar 2021
Why it stopped: Significant change in our clinic structure prevented continued recruitment of patients to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Imudia, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732469
- Sponsor's protocol ID
- 00037883
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ditkoff EC, Plumb J, Selick A, Sauer MV. Anesthesia practices in the United States common to in vitro fertilization (IVF) centers. J Assist Reprod Genet. 1997 Mar;14(3):145-7. doi: 10.1007/BF02766130.
PubMed 9090556Fiebai PO, Ogunmokun AA, Ajayi RA. Experience with conscious sedation for oocyte retrieval in Nigeria. Afr J Reprod Health. 2008 Apr;12(1):30-4.
PubMed 20695152Singhal H, Premkumar PS, Chandy A, Kunjummen AT, Kamath MS. Patient Experience with Conscious Sedation as a Method of Pain Relief for Transvaginal Oocyte Retrieval: A Cross Sectional Study. J Hum Reprod Sci. 2017 Apr-Jun;10(2):119-123. doi: 10.4103/jhrs.JHRS_113_16.
PubMed 28904501Gejervall AL, Stener-Victorin E, Moller A, Janson PO, Werner C, Bergh C. Electro-acupuncture versus conventional analgesia: a comparison of pain levels during oocyte aspiration and patients' experiences of well-being after surgery. Hum Reprod. 2005 Mar;20(3):728-35. doi: 10.1093/humrep/deh665. Epub 2004 Dec 17.
PubMed 15608039Ozaltin S, Kumbasar S, Savan K. Evaluation of complications developing during and after transvaginal ultrasound - guided oocyte retrieval. Ginekol Pol. 2018;89(1):1-6. doi: 10.5603/GP.a2018.0001.
PubMed 29411339Frederiksen Y, Mehlsen MY, Matthiesen SM, Zachariae R, Ingerslev HJ. Predictors of pain during oocyte retrieval. J Psychosom Obstet Gynaecol. 2017 Mar;38(1):21-29. doi: 10.1080/0167482X.2016.1235558. Epub 2016 Sep 27.
PubMed 27670651Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427van Hoogdalem E, de Boer AG, Breimer DD. Pharmacokinetics of rectal drug administration, Part I. General considerations and clinical applications of centrally acting drugs. Clin Pharmacokinet. 1991 Jul;21(1):11-26. doi: 10.2165/00003088-199121010-00002.
PubMed 1717195Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
PubMed 15195324
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients
- ClinicalTrials.gov ID
- NCT03732469
- Acronym / sponsor ID
- 00037883
- Conditions
- Opioid Use
- Keywords
- egg retrieval, oocyte retrieval, opioid dependence, rectal acetaminophen, rectal tylenol, pain, opioid use, opioid abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant change in our clinic structure prevented continued recruitment of patients to the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Nov 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.
The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.
Detailed description
As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl/propofol + acetaminophen | Experimental | Drug: Acetaminophen, Drug: Fentanyl, Drug: PropofolIn addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval. |
| Fentanyl/propofol only | Active comparator | Drug: Fentanyl, Drug: PropofolParticipants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture
Key exclusion criteria (7 listed)
- Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
- Patient with BMI greater than 40
- Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
- Patients with documented allergic reaction to acetaminophen
- Patient with contra-indication to the use of acetaminophen (liver 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 |
|---|---|---|
| AcetaminophenAlso: TylenolRectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval. | Drug | Fentanyl/propofol + acetaminophen |
| FentanylWeight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital | Drug | Fentanyl/propofol + acetaminophen, Fentanyl/propofol only |
| PropofolWeight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital | Drug | Fentanyl/propofol + acetaminophen, Fentanyl/propofol only |
Primary outcome
Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized
Time frame: 72 hours following oocyte retrieval
The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome.
4 secondary outcomes
Pain score in post-anesthesia care unit using the Visual Analog Scale
Time frame: 1-hour after oocyte retrieval
24-hour pain score using the Visual Analog Scale
Time frame: 24 hours after oocyte retrieval
48-hour pain score using the Visual Analog Scale measuring pain
Time frame: 48 hours after oocyte retrieval
72-hour pain score using the Visual Analog Scale measuring pain
Time frame: 72 hours after oocyte retrieval
Results and safety
The study was stopped early (reason given: Significant change in our clinic structure prevented continued recruitment of patients to the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 9090556Ditkoff EC, Plumb J, Selick A, Sauer MV. Anesthesia practices in the United States common to in vitro fertilization (IVF) centers. J Assist Reprod Genet. 1997 Mar;14(3):145-7. doi: 10.1007/BF02766130.
- Background: PubMed 20695152Fiebai PO, Ogunmokun AA, Ajayi RA. Experience with conscious sedation for oocyte retrieval in Nigeria. Afr J Reprod Health. 2008 Apr;12(1):30-4.
- Background: PubMed 28904501Singhal H, Premkumar PS, Chandy A, Kunjummen AT, Kamath MS. Patient Experience with Conscious Sedation as a Method of Pain Relief for Transvaginal Oocyte Retrieval: A Cross Sectional Study. J Hum Reprod Sci. 2017 Apr-Jun;10(2):119-123. doi: 10.4103/jhrs.JHRS_113_16.
- Background: PubMed 15608039Gejervall AL, Stener-Victorin E, Moller A, Janson PO, Werner C, Bergh C. Electro-acupuncture versus conventional analgesia: a comparison of pain levels during oocyte aspiration and patients' experiences of well-being after surgery. Hum Reprod. 2005 Mar;20(3):728-35. doi: 10.1093/humrep/deh665. Epub 2004 Dec 17.
- Background: PubMed 29411339Ozaltin S, Kumbasar S, Savan K. Evaluation of complications developing during and after transvaginal ultrasound - guided oocyte retrieval. Ginekol Pol. 2018;89(1):1-6. doi: 10.5603/GP.a2018.0001.
- Background: PubMed 27670651Frederiksen Y, Mehlsen MY, Matthiesen SM, Zachariae R, Ingerslev HJ. Predictors of pain during oocyte retrieval. J Psychosom Obstet Gynaecol. 2017 Mar;38(1):21-29. doi: 10.1080/0167482X.2016.1235558. Epub 2016 Sep 27.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 1717195van Hoogdalem E, de Boer AG, Breimer DD. Pharmacokinetics of rectal drug administration, Part I. General considerations and clinical applications of centrally acting drugs. Clin Pharmacokinet. 1991 Jul;21(1):11-26. doi: 10.2165/00003088-199121010-00002.
- Background: PubMed 15195324Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Anthony Imudia, MD principal investigator
University of South Florida
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 Acetaminophen, Fentanyl and Propofol in people with Opioid Use, run by University of South Florida 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jun 2021. 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. 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 stopped early (reason given: Significant change in our clinic structure prevented continued recruitment of patients to the study). Results are not available in the source record.
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?
Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized (time frame: 72 hours following oocyte retrieval). 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 NCT03732469, which also lists 9 linked publications.
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 18 Jun 2021.