Chronic Pain, PostoperativePhase 4NCT07888413
Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery
A Phase 4 study testing Esketamine combined with dexmedetomidine in people with Chronic Pain, Postoperative, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The goal of this clinical trial is to learn if low-dose esketamine combined with dexmedetomidine can reduce chronic pain after pancreatic surgery in adults. It will also learn about its safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Postoperative
- What is being tested?
- Esketamine combined with dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Nov 2029
- Phase
- Phase 4
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Body weight ≥40 kg.
- Scheduled for elective pancreatic surgery, including pancreaticoduodenectomy (Whipple procedure), pancreatectomy, or distal pancreatectomy.
- Planned use of postoperative patient-controlled intravenous analgesia (PCIA).
Who cannot join
- Refusal to participate in this study.
- Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), or second-degree or higher atrioventricular block without an implanted pacemaker; New York Heart Association (NYHA) functional class ≥ III.
- Preoperative diagnosis of sleep apnea, or STOP-Bang questionnaire score ≥3.
- Preoperative hyperthyroidism or a history of pheochromocytoma.
- Preoperative neuropsychiatric disorders, such as severe depression with suicidal ideation, dementia, schizophrenia, epilepsy, myasthenia gravis, and delirium.
- Severe hepatic impairment (Child-Pugh class C); severe renal impairment (receiving preoperative dialysis); ASA class ≥ IV.
- Unable to understand the visual analog scale or has language communication difficulties.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery: A Two-Center Randomized Controlled Trial
The goal of this clinical trial is to learn if low-dose esketamine combined with dexmedetomidine can reduce chronic pain after pancreatic surgery in adults. It will also learn about its safety. The main questions it aims to answer are:
- Does low-dose esketamine combined with dexmedetomidine lower the number of participants who have chronic pain 3 months after pancreatic surgery?
- What medical problems do participants have when receiving this treatment? Researchers will compare low-dose esketamine combined with dexmedetomidine to a control group (saline placebo during surgery and standard sufentanil patient-controlled intravenous analgesia after surgery) to see if the study treatment reduces chronic pain after pancreatic surgery. This is a two-center randomized controlled trial. About 450 adults will be enrolled and randomly assigned to the treatment group or the control group.
Read more
Participants will:
- Be adults aged 18 years or older, weigh at least 40 kg, and be scheduled for elective pancreatic surgery, including pancreaticoduodenectomy (Whipple procedure), pancreatectomy, or distal pancreatectomy.
- Receive the study drugs or placebo during surgery and use a patient-controlled intravenous pain pump after surgery.
- Be followed for up to 3 months after surgery to check for chronic pain.
- Conditions
- Chronic Pain, Postoperative
- Being tested
- Esketamine combined with dexmedetomidine, saline placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine combined with dexmedetomidineDrug
Intraoperative study drug: dexmedetomidine 1 mcg/mL + esketamine 0.5 mg/mL in 50 mL. Loading dose 0.3 mL/kg (dexmedetomidine 0.3 mcg/kg + esketamine 0.15 mg/kg) infused over 10 min, followed by continuous infusion 0.2 mL/kg/h (dexmedetomidine 0.2 mcg/kg/h + esketamine 0.1 mg/kg/h) until 30 min before the end of surgery.
Postoperative patient-controlled intravenous analgesia (PCIA): dexmedetomidine 1 mcg/mL + esketamine 0.5 mg/mL + sufentanil 1.5 mcg/kg in 100 mL. Continuous infusion 1 mL/h; bolus 2 mL per demand; lockout interval 8 min.
saline placeboDrug
Intraoperative placebo: normal saline in identical syringes and pump, administered using the same loading and continuous infusion regimen as the intervention group.
Postoperative PCIA: sufentanil 1.5 mcg/kg in 100 mL, using an identical patient-controlled intravenous analgesia pump. Continuous infusion 1 mL/h; bolus 2 mL per demand; lockout interval 8 min.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine + Dexmedetomidine | Experimental | Not described Receives: Drug: Esketamine combined with dexmedetomidine |
| Saline Placebo | Placebo comparator | Not described Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Chronic Pain at 3 Months After Pancreatic Surgery
The outcome measure reports the number and proportion of participants with chronic postsurgical pain (CPSP) at 3 months after pancreatic surgery. CPSP is assessed using the Chronic Postsurgical Pain (CPSP) Scale, a yes/no questionnaire. Participants are classified as having CPSP if they meet the following criteria: (1) pain lasting 3 months or longer after surgery; (2) pain is new after surgery or more painful than before surgery; (3) pain is localized to the surgical area; and (4) other causes of pain, such as local recurrence, infection, or metastasis, are excluded. The scale does not produce a numerical score.
Measured: At 3 months after pancreatic surgery
Secondary outcomes (6)
Cumulative Opioid Consumption Within 3 Days After Surgery
Cumulative opioid consumption within 3 days after surgery is a continuous measure of the total amount of opioids administered during the first 3 postoperative days . It is assessed from patient-controlled intravenous analgesia (PCIA) pump records and nursing medication administration records. The PCIA pump records the total volume of analgesic solution used; because the sufentanil concentration in the PCIA solution is known (sufentanil 1.5 μg/kg in 100 mL in both groups), the cumulative sufentanil dose delivered via PCIA is calculated. Any additional opioid rescue analgesia administered during this period (e.g., intravenous sufentanil boluses) is also recorded and included.
Measured: From the end of surgery to 3 days after surgery
Sleep Quality on the First 3 Postoperative Nights
Sleep quality during the first 3 postoperative nights is assessed on the mornings of postoperative days 1, 2, and 3 (8:00-10:00) for the previous night. Subjective sleep quality is measured using the Richards-Campbell Sleep Questionnaire (RCSQ) and a sleep Numeric Rating Scale (NRS). The RCSQ consists of 6 items, each scored on a 0-100 visual analogue scale, with higher scores indicating better sleep quality. The sleep NRS ranges from 0 to 10, where 0 indicates the best possible sleep quality and 10 indicates the worst possible sleep quality; therefore, higher NRS scores indicate worse sleep quality.
Measured: During the first 3 nights after surgery
Length of Postoperative Hospital Stay
This outcome measure reports the length of postoperative hospital stay as a continuous variable, measured in days. It is defined as the number of days from the date of surgery to the date of hospital discharge, as documented in the hospital medical record.
Measured: From the day of surgery to hospital discharge
Incidence of Postoperative Complications, Including All-Cause Mortality, Within 30 Days After Surgery
This outcome measure reports the incidence of participants who experience at least one postoperative complication, including all-cause mortality, within 30 days after pancreatic surgery. Pre-specified examples of complications include cardiac complications (myocardial injury or myocardial infarction, new-onset arrhythmia, acute heart failure, cardiac arrest), stroke, pulmonary complications (pneumonia, pulmonary aspiration, atelectasis, acute respiratory distress syndrome), acute renal insufficiency, gastrointestinal complications (gastrointestinal infarction, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction), and unplanned readmission.
Measured: Within 30 days after surgery
Depression Score at 3 Months After Surgery
Depression at 3 months after surgery is assessed using the Patient Health Questionnaire-9 (PHQ-9) , a 9-item self-reported depression screening questionnaire. Each item is scored from 0 to 3, and the total PHQ-9 score ranges from 0 to 27. A higher total score indicates more severe depressive symptoms.
Measured: At 3 months after surgery
EORTC QLQ-PAN26 Score at 3 Months After Surgery
The outcome measure reports the EORTC QLQ-PAN26 score at 3 months after surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26 (EORTC QLQ-PAN26) is a 26-item, pancreatic cancer-specific, patient-reported quality-of-life questionnaire module. Each item is rated on a 4-point Likert scale (1 = Not at all, 2 = A little, 3 = Somewhat, 4 = Very much).For symptom items, higher scores indicate more severe symptoms. For functional items, higher scores indicate better quality of life.
Measured: At 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain, PostoperativeStudies 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888413
- Sponsor's protocol ID
- E20260981
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No