Esketamine and Butorphanol for Post-Lobectomy Pain

NCT ID: NCT06398834

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Esketamine Pain Post-thoracotomy Pain Syndrome Thoracic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group BK

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type 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).

Butorphanol

Intervention Type DRUG

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

Group B

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.

Group Type PLACEBO_COMPARATOR

Butorphanol

Intervention Type DRUG

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

Interventions

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Esketamine

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).

Intervention Type DRUG

Butorphanol

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

Intervention Type DRUG

Other Intervention Names

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S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

Second People's Hospital of Hefei City

OTHER

Sponsor Role lead

Responsible Party

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Wang Hongjian

Attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xianwen Hu, PhD

Role: STUDY_CHAIR

The Second Hospital of Anhui Medical University

Wensheng He, MD

Role: STUDY_DIRECTOR

The Second People's Hospital of Hefei

Xin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Second People's Hospital of Hefei

Zicheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Second People's Hospital of Hefei

Junbao Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The Second People's Hospital of Hefei

Locations

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The Second People's Hospital of Hefei

Hefei, Anhui, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39751970 (View on PubMed)

Other Identifiers

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2022-keyan-007

Identifier Type: -

Identifier Source: org_study_id

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