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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06398834
Other study ID # 2022-keyan-007
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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