EndometriosisPhase 4NCT07182032
Ketamine in Central Sensitization
A Phase 4 study testing ketamine in people with Endometriosis and Chronic Pelvic Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Jun 2028
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age range 18-89
- ASA classification I-III
- outpatient elective laparoscopy for endometriosis
Who cannot join
- known allergy or contraindication to ketamine
- History of substance use disorder, including alcohol or marijuana use, both current and remote
- History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition , excluding anxiety and depression
- Current Intraoperative complications
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Ketamine Use in Central Sensitization: a Study Evaluating the Use of Ketamine in Centrally Sensitized Endometriosis Patients
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA.
Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Being tested
- ketamine
- Keywords
- ketamine, central sensitization
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Participants will receive general anesthesia with protocoled ketamine infusion
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | standard general anesthesia without ketamine |
| Ketamine | Experimental | standard general anesthesia with ketamine Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain as measured by visual analog scale
A Visual Analog Scale (VAS) is a tool for patients to rate their pain on a 100mm line, where "no pain" is at one end and "worst pain imaginable" is at the other.
Measured: approximately post-operative day 0 and 14
Secondary outcomes (6)
Intraoperative opioid consumption as measured by anesthesia charting
Reported in morphine equivalents
Measured: Intraoperatively up to 8 hours
change in postoperative pain scores measured by numerical rating scale
NRS is a simple and widely used pain assessment tool that asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (severe pain).
Measured: approximately postoperative day 0 and 14
incidence of postoperative nausea/vomiting as measured by patient report
Measured: postoperative day 0
change in total analgesic consumption post-surgery as measured by chart review and patient report
measured in morphine milliequivalents
Measured: approximately postoperative day 0, 1 and 14
incidence of postoperative delirium as measured by chart review
Measured: postoperative day 0
change in central sensitization as measured by central sensitization inventory (CSI) score
The CSI consists of 25 questions, each rated on a 0-4 scale (0 = never, 4 = always). The total score ranges from 0 to 100. Higher scores indicate a greater degree of central sensitization.
Measured: approximately postoperative day 0 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Study never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adi Cosic, DO, Principal investigator, University HospitalsMorgan Cheeks, MD, Principal investigator, University Hosptials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182032
- Sponsor's protocol ID
- STUDY20250700
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Use in Central Sensitization: a Study Evaluating the Use of Ketamine in Centrally Sensitized Endometriosis Patients
- ClinicalTrials.gov ID
- NCT07182032
- Acronym / sponsor ID
- STUDY20250700
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Keywords
- ketamine, central sensitization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Sep 2025 (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 purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA.
Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –standard general anesthesia without ketamine |
| Ketamine | Experimental | Drug: ketaminestandard general anesthesia with ketamine |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age range 18-89
- ASA classification I-III
- outpatient elective laparoscopy for endometriosis
Key exclusion criteria (4 listed)
- known allergy or contraindication to ketamine
- History of substance use disorder, including alcohol or marijuana use, both current and remote
- History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition , excluding anxiety and depression
- Current Intraoperative complications
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 |
|---|---|---|
| ketamineParticipants will receive general anesthesia with protocoled ketamine infusion | Drug | Ketamine |
Primary outcome
change in pain as measured by visual analog scale
Time frame: approximately post-operative day 0 and 14
A Visual Analog Scale (VAS) is a tool for patients to rate their pain on a 100mm line, where "no pain" is at one end and "worst pain imaginable" is at the other.
6 secondary outcomes
Intraoperative opioid consumption as measured by anesthesia charting
Time frame: Intraoperatively up to 8 hours
change in postoperative pain scores measured by numerical rating scale
Time frame: approximately postoperative day 0 and 14
incidence of postoperative nausea/vomiting as measured by patient report
Time frame: postoperative day 0
change in total analgesic consumption post-surgery as measured by chart review and patient report
Time frame: approximately postoperative day 0, 1 and 14
incidence of postoperative delirium as measured by chart review
Time frame: postoperative day 0
change in central sensitization as measured by central sensitization inventory (CSI) score
Time frame: approximately postoperative day 0 and 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- 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.
Adi Cosic, DO principal investigator
University Hospitals
Morgan Cheeks, MD principal investigator
University Hosptials
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 ketamine in people with Endometriosis and Chronic Pelvic Pain, run by University Hospitals Cleveland Medical Center 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 4 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: withdrawn, as of the sponsor's last update on 11 May 2026. 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 withdrawn before enrolling participants, so there are no results.
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 in pain as measured by visual analog scale (time frame: approximately post-operative day 0 and 14). 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 11 May 2026.