Effect of Esketamine and Lidocaine on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy

NCT06778460 | Recruiting DMC

• 1 other identifier: 2023-451-2
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months postoperatively

Secondary Outcomes (6)

• The incidence of chronic pain at 6 months and 1 year postoperatively

  Up to 1 year postoperatively

• Overall survival after surgery

  Up to 5 years postoperatively

• Recurrence-free survival after surgery

  Up to 5 years postoperatively

• Disability-free surviva survival

  Up to 5 years postoperatively

• The prevalence of neuropathic pain

  Up to 1 year postoperatively

Study Arms (2)

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.

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.

Other: Placebo group

Interventions

Esketamine-lidocaine group DRUG

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.

Also known as: Trial group

Esketamine-lidocaine group

Placebo group OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years;
• Scheduled for elective hepatectomy;
• ASA grade I-III.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: May 5, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

CN (1)