Esketamine and Butorphanol for Post-Lobectomy Pain
- Conditions
- EsketaminePost-thoracotomy Pain SyndromePainThoracic Diseases
- Interventions
- Registration Number
- NCT06398834
- Lead Sponsor
- Second People's Hospital of Hefei City
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 223
- Aged 20-70 years
- Classified as American Society of Anesthesiologists I-III
- Undergoing video-assisted lobectomy
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group BK Butorphanol 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. Group BK Esketamine 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. Group B Butorphanol 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.
- Primary Outcome Measures
Name Time Method Incidence of chronic pain 3 months post-surgery 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.
- Secondary Outcome Measures
Name Time Method Heart rate During operation The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs.
Acute pain after surgery Within 7 days 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.Postoperative recovery quality Preoperative and within 3 days after surgery 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).Intraoperative mean arterial pressure During operation The patient's intraoperative mean arterial pressure was recorded to assess the effect of esketamine on the patient's vital signs.
Trial Locations
- Locations (1)
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China