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Esketamine and Butorphanol for Post-Lobectomy Pain

Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06398834
Enrollment
223
Registered
2024-05-03
Start date
2022-03-01
Completion date
2024-01-01
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esketamine, Pain, Post-thoracotomy Pain Syndrome, Thoracic Diseases

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.

Interventions

DRUGEsketamine

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).

In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.

Sponsors

Tongji Hospital
CollaboratorOTHER
Second People's Hospital of Hefei City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of chronic pain3 months post-surgeryTo 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

MeasureTime frameDescription
Acute pain after surgeryWithin 7 days after surgeryTo 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 qualityPreoperative and within 3 days after surgeryThe 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 pressureDuring operationThe patient's intraoperative mean arterial pressure was recorded to assess the effect of esketamine on the patient's vital signs.
Heart rateDuring operationThe patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026