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NCT Number: NCT06398834

Esketamine and Butorphanol for Post-Lobectomy Pain

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.

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Key information

Conditions

Esketamine Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-thoracotomy Pain Syndrome Respiratory Tract Diseases Signs and Symptoms Thoracic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine

Butorphanol

Drug

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

Other names: Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex

Primary outcomes

  1. Incidence of chronic pain

    Time frame: 3 months post-surgery

    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.

Secondary outcomes

  1. Acute pain after surgery

    Time frame: Within 7 days 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.

  2. Postoperative recovery quality

    Time frame: Preoperative and within 3 days after surgery

    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).

  3. Intraoperative mean arterial pressure

    Time frame: During operation

    The patient's intraoperative mean arterial pressure was recorded to assess the effect of esketamine on the patient's vital signs.

  4. Heart rate

    Time frame: During operation

    The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs.

Sponsors and collaborators

Lead sponsor

Second People's Hospital of Hefei City

Other

Collaborators

  • Tongji Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 3, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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