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EsketaminePhase 4NCT06398834

Esketamine and Butorphanol for Post-Lobectomy Pain

A Phase 4 study testing Esketamine and Butorphanol in people with Esketamine and Pain, run by Second People's Hospital of Hefei City at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Esketamine, Pain, Post-thoracotomy Pain Syndrome
What is being tested?
Esketamine and Butorphanol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
223 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Esketamine, Butorphanol
Medical subject headings
Pain, Thoracic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsketamineDrug

    Also called S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine

    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).

  • ButorphanolDrug

    Also called Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex

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

Study groups in NCT06398834
Study groupRoleWhat they receive
Group BKExperimentalGroup 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.
Receives: Drug: Esketamine; Drug: Butorphanol
Group BPlacebo comparatorGroup 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.
Receives: Drug: Butorphanol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months post-surgery

Secondary outcomes (4)

  1. 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.

    Measured: Within 7 days after surgery

  2. 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).

    Measured: Preoperative and within 3 days after surgery

  3. 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.

    Measured: During operation

  4. Heart rate

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

    Measured: During operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start1 Mar 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398834
Sponsor's protocol ID
2022-keyan-007
Status last verified
May 2024
First submitted
23 Apr 2024
Last updated
6 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39751970

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esketamine and Butorphanol in people with Esketamine and Pain, run by Second People's Hospital of Hefei City at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of chronic pain (time frame: 3 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06398834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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