Oocyte Retrieival and Post Operative Pain ControlNCT05990868
Rectal Acetaminophen During Oocyte Retrievals
A study testing Tylenol in people with Oocyte Retrieival and Post Operative Pain Control, run by University of South Florida.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Oocyte Retrieival and Post Operative Pain Control
- What is being tested?
- Tylenol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Aug 2025
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
- Patient with BMI greater than 40
- Patients undergoing transabdominal ultrasound guided oocyte retrieval
- Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval.
- Patients with documented allergic reaction to acetaminophen or oxycodone
- Patient with contra-indication to the use of acetaminophen (liver disease)
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- Patients with a history of past or current alcohol, drug or opioid abuse.
- Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids.
- Patients who develop complication such as PID post procedure.
- -
About this study
Official title: Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients.
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 primary aim of this study is to evaluate whether or not the administration of rectal acetaminophen as an alternative analgesic at the completion of oocyte retrieval would reduce postoperative utilization of opioids (Tylenol with oxycodone) in fertility patients. 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.
Primary objective of the study will be to identify the proportion of prescribed Acetaminophen and Narcotics utilized 3 days following oocyte retrieval.
Read the detailed description
There are various methods of anesthesia used for transvaginal ultrasound guided oocyte retrievals. The majority of cases are performed under conscious sedation with a combination of sedative-hypnotic agents and analgesics while a small proportion of these retrievals are performed under general, regional, or local anesthesia. Conscious sedation is defined as, "a minimally depressed level of consciousness that retains the patient's ability to maintain a patent airway independently and continuously and to respond appropriately to physical stimulation and verbal commands."1 The most common agents chosen for conscious sedation are midazolam and/or Propofol with fentanyl for analgesia in some cases. One retrospective study looking at over a thousand patients undergoing oocyte retrieval at an in vitro fertilization (IVF) center found that no complications developed relating to anesthesia. Several cross-sectional studies looking at patients undergoing ultrasound-guided transvaginal follicle aspiration found that there was high patient satisfaction with a conscious sedation protocol of midazolam and opioid analgesia. Although this technique of conscious sedation has been the standard of care for several decades demonstrating good patient satisfaction and complications are rare, patients are still given oral opioids for postoperative pain. Given current opioid addiction crisis, it is prudent to challenge current practice by evaluating possible interventions that could help reduce both intraoperative and postoperative administration of opioids to fertility patients.
The pain experienced in oocyte retrieval is caused by the needle puncturing through the vaginal wall and by the mechanical stimulation of the ovary. This pain is often described as similar to intense menstrual cramping4. The retrospective study referenced above evaluated patients' self-reported degrees of pain and found that over 80% of patients undergoing oocyte retrieval reported having only mild pain or no pain at all5. Another study found that 6.9% of patients undergoing oocyte retrieval reported the procedure to be very or extremely painful with significant predictors of pain being negative gynecological experiences, having experienced side effects during their hormonal treatment, higher levels of intraoperative anxiety, lower levels of perceived control, and longer duration of the retrieval procedure.
Given that most patients seem to tolerate the procedure well, this is a potential clinical area in which opioid use could be minimized, or even eliminated, and non-opioid analgesia could be employed instead.
The current opioid addiction epidemic is one that has been called the "most consequential preventable public health problem in the United States." Although the in-vitro fertilization demographic is not typically associated with substance abuse, it is thought that about six percent of opioid naïve patients are at an increased risk for abusing the medication after surgery and developing new persistent opioid use after being prescribed opioids after an elective surgical procedure. In a study by Bortelleto et al it was reported that approximately 12 % of women fill up opioid prescription after oocyte retrieval8. In a recent study by Petrozza et al evaluated use of IV Acetaminophen in oocyte retrieval and reported that preoperative IV acetaminophen did not reduce postoperative pain scores or shorten the time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently be recommended routinely in this patient population. Thus, the purpose of this study is to evaluate whether intra-procedure administration of rectal Acetaminophen would be sufficient to manage postoperative pain after oocyte retrievals and could help decrease utilization of prescribed opioid at home following oocyte retrieval.
The primary outcome of this study is to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
- Being tested
- Tylenol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TylenolDrug
Rectal tylenol will be placed at the time of oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| Rectal tylenol group: Group 1 | Active comparator | Randomization to the study group (Group 1): will receive standard anesthesia and 650 mg rectal Tylenol at the time of egg retrieval. Receives: Drug: Tylenol |
| Placebo group: Group 2 | Placebo comparator | Randomization to the standard of care group (Group 2): will receive standard anesthesia and rectal placebo at the time of oocyte retrieval. Placebo is a substance that has no therapeutic effect and used as a control in testing new drugs. Receives: Drug: Tylenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate reduction in opioid use post oocyte retrieval
to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte Retrieival and Post Operative Pain ControlStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary outcome in this study is the proportion of the prescribed medications used three days after discharge from the surgery. Assuming that only one third or less of the Narcotics prescribed (2 out of 6 tablets) in Group 1 will be utilized as compared to two thirds or more (4 out of 6 tables) in group 2, 35 patients in each group will be required to achieve 80% power and two-sided level of significance of 0.058. Given we expect possible 10% drop out rate after randomization, we plan to recruit 39 patients in each group (78 total sample). We plan to perform our analysis using SPSS.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Imudia, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990868
- Sponsor's protocol ID
- STUDY005325
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. 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
- NCT05990868
- Acronym / sponsor ID
- STUDY005325
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
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 primary aim of this study is to evaluate whether or not the administration of rectal acetaminophen as an alternative analgesic at the completion of oocyte retrieval would reduce postoperative utilization of opioids (Tylenol with oxycodone) in fertility patients. 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.
Primary objective of the study will be to identify the proportion of prescribed Acetaminophen and Narcotics utilized 3 days following oocyte retrieval.
Detailed description
There are various methods of anesthesia used for transvaginal ultrasound guided oocyte retrievals. The majority of cases are performed under conscious sedation with a combination of sedative-hypnotic agents and analgesics while a small proportion of these retrievals are performed under general, regional, or local anesthesia. Conscious sedation is defined as, "a minimally depressed level of consciousness that retains the patient's ability to maintain a patent airway independently and continuously and to respond appropriately to physical stimulation and verbal commands."1 The most common agents chosen for conscious sedation are midazolam and/or Propofol with fentanyl for analgesia in some cases. One retrospective study looking at over a thousand patients undergoing oocyte retrieval at an in vitro fertilization (IVF) center found that no complications developed relating to anesthesia. Several cross-sectional studies looking at patients undergoing ultrasound-guided transvaginal follicle aspiration found that there was high patient satisfaction with a conscious sedation protocol of midazolam and opioid analgesia. Although this technique of conscious sedation has been the standard of care for several decades demonstrating good patient satisfaction and complications are rare, patients are still given oral opioids for postoperative pain. Given current opioid addiction crisis, it is prudent to challenge current practice by evaluating possible interventions that could help reduce both intraoperative and postoperative administration of opioids to fertility patients.
The pain experienced in oocyte retrieval is caused by the needle puncturing through the vaginal wall and by the mechanical stimulation of the ovary. This pain is often described as similar to intense menstrual cramping4. The retrospective study referenced above evaluated patients' self-reported degrees of pain and found that over 80% of patients undergoing oocyte retrieval reported having only mild pain or no pain at all5. Another study found that 6.9% of patients undergoing oocyte retrieval reported the procedure to be very or extremely painful with significant predictors of pain being negative gynecological experiences, having experienced side effects during their hormonal treatment, higher levels of intraoperative anxiety, lower levels of perceived control, and longer duration of the retrieval procedure.
Given that most patients seem to tolerate the procedure well, this is a potential clinical area in which opioid use could be minimized, or even eliminated, and non-opioid analgesia could be employed instead.
The current opioid addiction epidemic is one that has been called the "most consequential preventable public health problem in the United States." Although the in-vitro fertilization demographic is not typically associated with substance abuse, it is thought that about six percent of opioid naïve patients are at an increased risk for abusing the medication after surgery and developing new persistent opioid use after being prescribed opioids after an elective surgical procedure. In a study by Bortelleto et al it was reported that approximately 12 % of women fill up opioid prescription after oocyte retrieval8. In a recent study by Petrozza et al evaluated use of IV Acetaminophen in oocyte retrieval and reported that preoperative IV acetaminophen did not reduce postoperative pain scores or shorten the time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently be recommended routinely in this patient population. Thus, the purpose of this study is to evaluate whether intra-procedure administration of rectal Acetaminophen would be sufficient to manage postoperative pain after oocyte retrievals and could help decrease utilization of prescribed opioid at home following oocyte retrieval.
The primary outcome of this study is to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The primary outcome in this study is the proportion of the prescribed medications used three days after discharge from the surgery. Assuming that only one third or less of the Narcotics prescribed (2 out of 6 tablets) in Group 1 will be utilized as compared to two thirds or more (4 out of 6 tables) in group 2, 35 patients in each group will be required to achieve 80% power and two-sided level of significance of 0.058. Given we expect possible 10% drop out rate after randomization, we plan to recruit 39 patients in each group (78 total sample). We plan to perform our analysis using SPSS.
| Arm | Type | Receives |
|---|---|---|
| Rectal tylenol group: Group 1 | Active comparator | Drug: TylenolRandomization to the study group (Group 1): will receive standard anesthesia and 650 mg rectal Tylenol at the time of egg retrieval. |
| Placebo group: Group 2 | Placebo comparator | Drug: TylenolRandomization to the standard of care group (Group 2): will receive standard anesthesia and rectal placebo at the time of oocyte retrieval. Placebo is a substance that has no therapeutic effect and used as a control in testing new drugs. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
- Patient with BMI greater than 40
- Patients undergoing transabdominal ultrasound guided oocyte retrieval
- Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval.
- Patients with documented allergic reaction to acetaminophen or oxycodone
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 |
|---|---|---|
| TylenolRectal tylenol will be placed at the time of oocyte retrieval | Drug | Placebo group: Group 2, Rectal tylenol group: Group 1 |
Primary outcome
Evaluate reduction in opioid use post oocyte retrieval
Time frame: 1 year
to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tylenol in people with Oocyte Retrieival and Post Operative Pain Control, run by University of South Florida.
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 0 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this 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?
Evaluate reduction in opioid use post oocyte retrieval (time frame: 1 year). 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 14 Aug 2023.