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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BK | Experimental | 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. |
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| Group B | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xianwen Hu, PhD | The Second Hospital of Anhui Medical University | Study Chair |
| Wensheng He, MD | The Second People's Hospital of Hefei | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Hefei | Hefei | Anhui | 230011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39751970 | Derived | Wang H, Wang Z, Zhang J, Wang X, Fan B, He W, Hu X. Perioperative esketamine combined with butorphanol versus butorphanol alone for pain management following video-assisted lobectomy: a randomized controlled trial. Int J Clin Pharm. 2025 Apr;47(2):452-461. doi: 10.1007/s11096-024-01850-7. Epub 2025 Jan 3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2024 | |
| Unrelease | May 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2024 | May 21, 2024 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D007649 | Ketamine |
| D002077 | Butorphanol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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The enrolled participants were randomly allocated to either the butorphanol group (Group B) or the esketamine combined with butorphanol group (Group BK) at a 1:1 ratio.
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| Butorphanol | Drug | In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine. |
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| 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 |
| Heart rate | The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs. | During operation |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |