Esketamine and Butorphanol for Post-Lobectomy Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Thoracic Diseases; Esketamine; Post-thoracotomy Pain Syndrome
• Intervention / Treatment: Drug: Butorphanol; Drug: Esketamine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230011
      • The Second People's Hospital of Hefei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group BK; 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.	Drug: Butorphanol; In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.; Other Names: Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex; 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).; Other Names: S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine
Placebo Comparator: Group B; 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.	Drug: Butorphanol; In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.; Other Names: Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs.	During operation
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
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
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

Collaborators and Investigators

• Sponsor: Second People's Hospital of Hefei City
• Collaborators: Tongji Hospital
• Investigators: Study Chair: Xianwen Hu, PhD, The Second Hospital of Anhui Medical University; Study Director: Wensheng He, MD, The Second People's Hospital of Hefei; Principal Investigator: Xin Wang, MD, The Second People's Hospital of Hefei; Principal Investigator: Zicheng Wang, MD, The Second People's Hospital of Hefei; Principal Investigator: Junbao Zhang, MD, The Second People's Hospital of Hefei

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Ketamine; Esketamine; Butorphanol
• Other Study ID Numbers: 2022-keyan-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No