Esketamine and Butorphanol for Post-Lobectomy Pain

NCT06398834 | Completed Phase 4

• 1 other identifier: 2022-keyan-007
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute pain after surgery

  Within 7 days after surgery

• Postoperative recovery quality

  Preoperative and within 3 days after surgery

• Intraoperative mean arterial pressure

  During operation

• Heart rate

  During operation

Study Arms (2)

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.

Drug: Esketamine; Drug: Butorphanol

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.

Drug: Butorphanol

Interventions

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).

Also known as: S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine

Group BK

Butorphanol DRUG

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

Also known as: Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex

Group B; Group BK

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-70 years
• Classified as American Society of Anesthesiologists I-III
• Undergoing video-assisted lobectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second People's Hospital of Hefei City: lead
• Tongji Hospital: collaborator

Study Sites (1)

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

Location

Related Publications (1)

• 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.

  PMID: 39751970 DERIVED

MeSH Terms

Conditions

Pain; Thoracic Diseases

Interventions

Esketamine; Ketamine; Butorphanol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 3, 2024
• Study Start: March 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

CN (1)