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CompletedNCT06559280Updated Feb 11, 2026

The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy

An Early Phase 1 interventional study of esketamine in Ectopic Pregnancy, sponsored by Fujian Provincial Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Fujian Provincial Hospital · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Ectopic Pregnancy

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03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 84 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Fujian Provincial Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age>18 years old
  • 18-30 kg/m2;
  • (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

Exclusion criteria

Exclusion Criteria:

  • 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 for the use of ketamine in cases of hyperthyroidism Refuse to join the trial;
  • Patients with a history of other chronic pain diseases.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    experimental group

    Use ketamine for postoperative analgesia and intraoperative induction

    Drug: esketamine

  • No intervention
    control group

    Not using ketamine for postoperative analgesia and intraoperative induction

Interventions

  • During the operation, 0.25mg/kg esketamine was induced, and 1mg/kg esketamine was added to the postoperative analgesia pump

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperative, one day after surgery, the second day after surgery, and one week after surgery

07

Study locations

1 site
  • Fuzhou University affiliated Provincial Hospital
    Fuzhou, Fujian 350001, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06559280
Lead sponsor
Fujian Provincial Hospital
Responsible party
Wu Yanqin (physician, Fujian Provincial Hospital) — Principal investigator
First posted
Aug 19, 2024
Start date
Aug 24, 2024
Primary completion
Aug 20, 2025
Completion
Aug 20, 2025
Last update
Feb 11, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Esketamine

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