Esketamine and Butorphanol for Post-Lobectomy Pain

Second People's Hospital of Hefei City

Status and phase: Completed; Phase 4

Conditions: Esketamine; Thoracic Diseases; Post-thoracotomy Pain Syndrome; Pain

Treatments: Drug: Butorphanol; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06398834

2022-keyan-007

Details and patient eligibility

About

Post-thoracotomy pain syndrome (PTPS) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. The analgesic effect of esketamine combined with butorphanol in PTPS is still unclear, so this study focused on this aspect.

Full description

Post-thoracotomy pain syndrome affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. Esketamine, the left-handed optical isomer of racemic ketamine, acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor, reversing central sensitization and improving postoperative pain. Butorphanol, an opioid receptor agonist-antagonist, can alleviate visceral pain, reduce the risk of respiratory depression, and decrease postoperative morphine consumption. However, research on the analgesic effects of esketamine combined with butorphanol in thoracoscopic surgery remains limited. Therefore, this study investigated the impact of esketamine combined with butorphanol on acute pain, chronic pain, and related side effects during the perioperative period in patients undergoing video-assisted lobectomy.

Enrollment: 223 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 20-70 years
• Classified as American Society of Anesthesiologists I-III
• Undergoing video-assisted lobectomy

Exclusion criteria

• Operative duration < 1 hour
• Significant comorbidities affecting vital organs such as liver, kidney, and heart
• Severe infections
• Immunodeficiency
• Coagulation disorders
• History of analgesic drug abuse
• Severe dementia or communication barriers
• Mental illnesses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

223 participants in 2 patient groups, including a placebo group

Group BK

Experimental group

Description:

Group BK received esketamine infusion at a rate of 0.3 mg/kg/h during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing esketamine (1.5 mg/kg), butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.

Treatment:

Drug: Esketamine

Drug: Butorphanol

Group B

Placebo Comparator group

Description:

Group B received an equivalent volume of saline during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.

Treatment:

Drug: Butorphanol