Ectopic PregnancyEarly Phase 1NCT06559280
The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy
A Early Phase 1 study testing esketamine in people with Ectopic Pregnancy, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
The experiment aims to explore the clinical effect of subclinical doses of ketamine on early postoperative pain sensitivity in ectopic pregnancy population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2024to 20 Aug 2025
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old
- BMI 18-30 kg/m2;
- American Society of Anesthesiologists (ASA) classification I and II
- The patient was diagnosed with ectopic pregnancy through ultrasound examination, and it was confirmed that there was no embryo or gestational sac in the uterus; The patient has indications for laparoscopic ectopic pregnancy surgery;
- All patients are scheduled to undergo laparoscopic salpingectomy for treatment Normal mental state;
- No cognitive impairment;
- Normal communication skills, no speech barriers
Who cannot join
- Individuals with severe organ dysfunction such as heart, lungs, liver, and kidneys;
- Individuals with serious mental illnesses;
- Long term use of sedatives and analgesics or long-term alcoholism and smoking;
- History of allergy to ketamine and related drugs
- There is a serious risk of hypertension or elevated intracranial pressure, as well as contraindications for the use of ketamine in cases of hyperthyroidism Refuse to join the trial;
- Patients with a history of other chronic pain diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuzhou University affiliated Provincial Hospital
Fuzhou, Fujian, 350001
About this study
Official title: The Effect of Subclinical Doses of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy: a Prospective, Double-blind, Randomized Controlled Clinical Trial
The experiment aims to explore the clinical effect of subclinical doses of ketamine on early postoperative pain sensitivity in ectopic pregnancy population.
Read the detailed description
Ectopic pregnancy (EP) refers to the implantation and development of a fertilized egg outside the uterine cavity, and is one of the common acute abdominal conditions in obstetrics and gynecology. Among them, tubal pregnancy is the most common type, with the highest incidence rate among all ectopic pregnancies. After falling ill, it is easy for patients to experience symptoms such as vaginal bleeding, abdominal pain, and amenorrhea, and even infertility, which seriously affects their physical and mental health. After diagnosis, patients often experience negative emotions such as anxiety, fear, and depression. A history of preoperative anxiety and depression can lower the patient's pain threshold, leading to poor postoperative pain control. In gynecological laparoscopic surgery, ectopic pregnancy surgery is also a relatively painful type of surgery, and the establishment of pneumoperitoneum during surgery can easily cause postoperative pain and affect the patient's prognosis and quality of life. And the patient's preoperative preparation time is limited, leading to a decrease in pain tolerance and an increased demand for postoperative analgesia . Therefore, the issue of increased postoperative pain sensitivity in patients with ectopic pregnancy deserves attention.
Ketamine is an N-methyl-D-aspartate (NMDA) receptor inhibitor that can effectively inhibit NMDA receptor-mediated central sensitization. As an adjuvant analgesic for preventing postoperative hyperalgesia induced by remifentanil, it has a definite therapeutic effect . Esketamine, also known as right ketamine, has pharmacological characteristics similar to racemic ketamine while enhancing analgesic and sedative effects, helping to reduce perioperative opioid use. It has also shown significant advantages in the treatment of pain sensitivity, depression, and epilepsy . However, there are relatively few studies on the postoperative pain sensitivity of subclinical doses of ketamine and ectopic pregnancy patients in clinical practice, and whether it can improve postoperative pain sensitivity in such patients still needs further research and exploration.
- Conditions
- Ectopic Pregnancy
- Being tested
- esketamine
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamineDrug
During the operation, 0.25mg/kg esketamine was induced, and 1mg/kg esketamine was added to the postoperative analgesia pump
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Use ketamine for postoperative analgesia and intraoperative induction Receives: Drug: esketamine |
| control group | No intervention | Not using ketamine for postoperative analgesia and intraoperative induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain sensitivity
The pain sensitivity scale is used to measure the pain sensitivity of patients. Patients imagine certain scenarios in their daily lives and score their pain to evaluate their individual pain sensitivity. This scale contains 17 items, requiring testers to fill in a number on the numerical rating scale from 0 (no pain) to 10 (most pain) to indicate the degree of pain in this situation. There are three items interspersed among them that describe situations where there is no pain under normal circumstances, as a reference for testers to feel no pain. In addition, the 14 pain items cover various types of pain and pain intensity levels, and completing the PSQ generally takes 5-10 minutes. The total score of PSQ is based on the average score of 14 pain items, ranging from 0 to 10. The results are divided into two categories: PSQ moderate and PSQ minor, which reflect the expected pain levels of different intensity stimuli. The higher the score, the more sensitive it is to pain stimuli.
Measured: Preoperative, one day after surgery, the second day after surgery, and one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start24 Aug 2024
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Yanqin, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559280
- Sponsor's protocol ID
- K2023-11-022
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subclinical Doses of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy: a Prospective, Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06559280
- Acronym / sponsor ID
- K2023-11-022
- Conditions
- Ectopic Pregnancy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 19 Aug 2024 (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 experiment aims to explore the clinical effect of subclinical doses of ketamine on early postoperative pain sensitivity in ectopic pregnancy population.
Detailed description
Ectopic pregnancy (EP) refers to the implantation and development of a fertilized egg outside the uterine cavity, and is one of the common acute abdominal conditions in obstetrics and gynecology. Among them, tubal pregnancy is the most common type, with the highest incidence rate among all ectopic pregnancies. After falling ill, it is easy for patients to experience symptoms such as vaginal bleeding, abdominal pain, and amenorrhea, and even infertility, which seriously affects their physical and mental health. After diagnosis, patients often experience negative emotions such as anxiety, fear, and depression. A history of preoperative anxiety and depression can lower the patient's pain threshold, leading to poor postoperative pain control. In gynecological laparoscopic surgery, ectopic pregnancy surgery is also a relatively painful type of surgery, and the establishment of pneumoperitoneum during surgery can easily cause postoperative pain and affect the patient's prognosis and quality of life. And the patient's preoperative preparation time is limited, leading to a decrease in pain tolerance and an increased demand for postoperative analgesia . Therefore, the issue of increased postoperative pain sensitivity in patients with ectopic pregnancy deserves attention.
Ketamine is an N-methyl-D-aspartate (NMDA) receptor inhibitor that can effectively inhibit NMDA receptor-mediated central sensitization. As an adjuvant analgesic for preventing postoperative hyperalgesia induced by remifentanil, it has a definite therapeutic effect . Esketamine, also known as right ketamine, has pharmacological characteristics similar to racemic ketamine while enhancing analgesic and sedative effects, helping to reduce perioperative opioid use. It has also shown significant advantages in the treatment of pain sensitivity, depression, and epilepsy . However, there are relatively few studies on the postoperative pain sensitivity of subclinical doses of ketamine and ectopic pregnancy patients in clinical practice, and whether it can improve postoperative pain sensitivity in such patients still needs further research and exploration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: esketamineUse ketamine for postoperative analgesia and intraoperative induction |
| control group | No intervention | –Not using ketamine for postoperative analgesia and intraoperative induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age>18 years old
- BMI 18-30 kg/m2;
- American Society of Anesthesiologists (ASA) classification I and II
- The patient was diagnosed with ectopic pregnancy through ultrasound examination, and it was confirmed that there was no embryo or gestational sac in the uterus; The patient has indications for laparoscopic ectopic pregnancy surgery;
- All patients are scheduled to undergo laparoscopic salpingectomy for treatment Normal mental state;
Key exclusion criteria (6 listed)
- Individuals with severe organ dysfunction such as heart, lungs, liver, and kidneys;
- Individuals with serious mental illnesses;
- Long term use of sedatives and analgesics or long-term alcoholism and smoking;
- History of allergy to ketamine and related drugs
- There is a serious risk of hypertension or elevated intracranial pressure, as well as contraindications for the use of ketamine in cases of hyperthyroidism Refuse to join the trial;
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 |
|---|---|---|
| esketamineDuring the operation, 0.25mg/kg esketamine was induced, and 1mg/kg esketamine was added to the postoperative analgesia pump | Drug | experimental group |
Primary outcome
Postoperative pain sensitivity
Time frame: Preoperative, one day after surgery, the second day after surgery, and one week after surgery
The pain sensitivity scale is used to measure the pain sensitivity of patients. Patients imagine certain scenarios in their daily lives and score their pain to evaluate their individual pain sensitivity. This scale contains 17 items, requiring testers to fill in a number on the numerical rating scale from 0 (no pain) to 10 (most pain) to indicate the degree of pain in this situation. There are three items interspersed among them that describe situations where there is no pain under normal circumstances, as a reference for testers to feel no pain. In addition, the 14 pain items cover various types of pain and pain intensity levels, and completing the PSQ generally takes 5-10 minutes. The total score of PSQ is based on the average score of 14 pain items, ranging from 0 to 10. The results are divided into two categories: PSQ moderate and PSQ minor, which reflect the expected pain levels of different intensity stimuli. The higher the score, the more sensitive it is to pain stimuli.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
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 Early Phase 1 study testing esketamine in people with Ectopic Pregnancy, run by Fujian Provincial Hospital at 1 site in China.
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 7 inclusion and 6 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 11 Feb 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain sensitivity (time frame: Preoperative, one day after surgery, the second day after surgery, and one week after surgery). 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 Feb 2026.