Postoperative Chronic PainNCT06778460
Effect of Esketamine and Lidocaine on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy
A study testing Esketamine-lidocaine group in people with Postoperative Chronic Pain, run by West China Hospital at 1 site in China.
Trial summary
This study is a further observation and follow-up of the patients enrolled in the registration number ChiCTR230007164430 to further evaluate the effect of long-term infusion of esketamine and lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Chronic Pain
- What is being tested?
- Esketamine-lidocaine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 31 Mar 2027
- Phase
- Interventional
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- Scheduled for elective hepatectomy;
- ASA grade I-III.
Who cannot join
- Patients who have been intubated in the ICU following surgery and do not have a planned extubation within 6 hours postoperatively.
- Patients with a body weight less than 40 kg or greater than 100 kg.
- Patients with cardiac conduction system abnormalities (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction < 50%).
- Patients with severe hepatic insufficiency (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or bilirubin levels more than 2.5 times the upper limit of normal) or renal insufficiency (creatinine clearance rate < 60 mL/min).
- Patients with a known hypersensitivity to the investigational drug.
- Patients with a history of long-term opioid abuse.
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- Patients who are unable to communicate effectively.
- Patients with serious comorbid medical conditions, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, or acute asthma exacerbations.
- Patients with a history of epilepsy or a history of manic episodes.
- Pregnant or breastfeeding women.
- Patients with glaucoma.
- Patients with preoperative cognitive dysfunction, bipolar disorder, or other psychiatric disorders, including mental retardation.
- Patients with primary liver cancer in conjunction with malignant tumors of other organs (such as lung, kidney, intestine, etc.), or those with clinical symptoms or imaging findings suggestive of distant metastasis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Chunling Jiang, PhD, 18980601096
About this study
Official title: Effect of Perioperative Continuous Intravenous Infusion of Esketamine and Lidocaine on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy
This study is a further observation and follow-up of the patients enrolled in the registration number ChiCTR230007164430 to further evaluate the effect of long-term infusion of esketamine and lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing hepatectomy.
Read the detailed description
This study is a further observation and follow-up of the patients enrolled in the registration number ChiCTR230007164430 to further evaluate the effect of long term infusion of esketamine and lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing hepatectomy. 304 patients with primary liver cancer who meet the inclusion criteria were included. According to the random number, the patients were divided into esketamine-lidocaine group and conventional analgesia group. In the esketamine-lidocaine group, patients received esketamine (0.25 mg/kg) and lidocaine (1.5 mg/kg) at the induction of anesthesia, followed by the continuous infusion of esketamine (0.02 mg/kg∙h) and lidocaine (1.5 mg/kg∙h) until the end of surgery. Postoperatively, the patients used 2 pumps. One pump delivered a fixed-rate infusion of lidocaine at 1.0 mg.kg-1.h-1 and esketamine at 0.02 mg.kg-1.h-1 infusion for 72 hours. Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline instead of lidocaine and esketamine will be administered. Numeric rating scale (NRS) is used to evaluate pain at rest and light activities at postoperative 24, 48, 72 hours. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.
- Conditions
- Postoperative Chronic Pain
- Being tested
- Esketamine-lidocaine group, Placebo group
- 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-lidocaine groupDrug
Also called Trial group
In the esketamine-lidocaine group, patients received esketamine (0.25 mg/kg) and lidocaine (1.5 mg/kg) at the induction of anesthesia, followed by the continuous infusion of esketamine (0.02 mg/kg∙h) and lidocaine (1.5 mg/kg∙h) until the end of surgery. Postoperatively, the patients received two pumps. One pump delivered a fixed-rate infusion of lidocaine at 1.0 mg.kg-1.h-1 and esketamine at 0.02 mg.kg-1.h-1 infusion for 72 hours. Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline.
Placebo groupOther
In the conventional analgesia group, patients received the same volume of normal saline instead of lidocaine and esketamine until the end of surgery. Postoperatively, the paitents received two pumps. One pump was the same volume of normal saline instead of lidocaine and esketamine. Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine-lidocaine group | Experimental | Patients received esketamine (0.25 mg/kg) and lidocaine (1.5 mg/kg) at the induction of anesthesia, followed by the continuous infusion of esketamine (0.02 mg/kg∙h) and lidocaine (1.5 mg/kg∙h) until the end of surgery. Postoperatively, the patients received two pumps. One pump delivered a fixed-rate infusion of lidocaine at 1.0 mg.kg-1.h-1 and esketamine at 0.02 mg.kg-1.h-1 infusion for 72 hours. Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. Receives: Drug: Esketamine-lidocaine group |
| Placebo group | Placebo comparator | Patients received the same volume of normal saline instead of lidocaine and esketamine until the end of surgery. Postoperatively, the patients received two pumps. One pump was the same volume of normal saline instead of lidocaine and esketamine. Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic pain at 3 months postoperatively
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience. The impact of chronic pain on the quality of life is also assessed by Brief Pain Inventory score.
Measured: 3 months postoperatively
Secondary outcomes (6)
The incidence of chronic pain at 6 months and 1 year postoperatively
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience. The impact of chronic pain on the quality of life is also assessed by Brief Pain Inventory score.
Measured: Up to 1 year postoperatively
Overall survival after surgery
Overall survival is defined as the time between the date from surgery to the date of death.
Measured: Up to 5 years postoperatively
Recurrence-free survival after surgery
Postoperative re-examination is based on the diagnosis of enhanced CT, MRI, ultrasound or blood examination to determine whether the patient has recurrence and metastasis. Recurrence-free time refers to the time from surgery to tumor recurrence based on the above CT, MRI, etc.
Measured: Up to 5 years postoperatively
Disability-free surviva survival
Patient self-assessment is carried out by using the World Health Organization(WHO) Disability Scale, with a minimum score of 12 points and a maximum score of 60 points. The lower the score, the higher the quality of life.
Measured: Up to 5 years postoperatively
The prevalence of neuropathic pain
The ID Pain scale is used as a validated assessment of neuropathic pain. ID pain questionnaire consists of six items.
Pain higher scores suggest a neuropathic component to the pain.
Measured: Up to 1 year postoperatively
Brief Pain Inventory(BPI) pain interference subscale score
BPI pain interference subscale is a 7-item questionnaire asking participants to describe how pain has interfered general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life. Each question is answered on a scale 0(does not interfere) to 10(completely interferes). The total range of score is 0-70. The higher the scores suggest the worse the interference.
Measured: Up to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start5 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Chronic PainStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778460
- Sponsor's protocol ID
- 2023-451-2
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No