Clinical trial NCT06398834: Esketamine and Butorphanol for Post-Lobectomy Pain
Official title: Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esketamine
Pain
Post-thoracotomy Pain Syndrome
Thoracic Diseases
Lead sponsor: Second People's Hospital of Hefei City
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
First posted: 2024-05-03
Enrollment: 223
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of chronic pain
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Acute pain after surgery
timeFrame: Within 7 days after surgery
measure: Postoperative recovery quality
timeFrame: Preoperative and within 3 days after surgery
measure: Intraoperative mean arterial pressure
timeFrame: During operation
measure: Heart rate
timeFrame: During operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Xianwen Hu, PhD
role: STUDY_CHAIR
affiliation: The Second People's Hospital of Hefei
name: Wensheng He, MD
role: STUDY_DIRECTOR
affiliation: The Second People's Hospital of Hefei
name: Xin Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second People's Hospital of Hefei
name: Zicheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second People's Hospital of Hefei
name: Junbao Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: