Esketamine and Butorphanol for Post-Lobectomy Pain

Pain Clinical Trial

Official title:

Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06398834
• Other study ID #: 2022-keyan-007
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2024
• Source: Second People's Hospital of Hefei City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esketamine
• Pain
• Post-thoracotomy Pain Syndrome
• Thoracic Diseases

Intervention

Drug:
• Esketamine
In the esketamine combined with butorphanol group (Group BK), patients received an intraoperative intravenous infusion of esketamine (0.3 mg/kg/h) followed by postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg + butorphanol 0.15 mg/kg + azasetron 20 mg).
• Butorphanol
In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.

Locations

Country	Name	City	State
China	The Second People's Hospital of Hefei	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Second People's Hospital of Hefei City	Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic pain	To assess the patient's subjective pain intensity through the Visual Analog Pain Scale at 3 months after surgery.; The Visual Analog Pain Scale consists of a line usually 100 mm in length. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (no pain) to the right (worst pain). The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.	3 months post-surgery
Secondary	Acute pain after surgery	To assess the postoperative pain intensity of each participant through the Visual Analog Pain Scale at 6, 12 hours, and 1, 2, 3, 5, and 7 days following surgery.; The Visual Analog Pain Scale consists of a line usually 100 mm in length. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (no pain) to the right (worst pain). The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.	Within 7 days after surgery
Secondary	Postoperative recovery quality	The quality of recovery was assessed by 15-item quality of recovery (QoR-15) before surgery, on postoperative day (POD) 1, and POD 3.; The QoR-15 is a recently developed and validated short-form postoperative QoR score. Fifteen questions assess five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).	Preoperative and within 3 days after surgery
Secondary	Intraoperative mean arterial pressure	The patient's intraoperative mean arterial pressure was recorded to assess the effect of esketamine on the patient's vital signs.	During operation
Secondary	Heart rate	The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs.	During operation