Pain Clinical Trial
Official title:
Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy
Verified date | May 2024 |
Source | Second People's Hospital of Hefei City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The Second People's Hospital of Hefei | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Second People's Hospital of Hefei City | Tongji Hospital |
China,
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 |
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