Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy

NCT06570538 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ATHGuangzhou.
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators have designed a randomized controlled trial. Utilizing an open-label, randomized, controlled study methodology, this trial aims to explore a opioid-free, safe, and effective analgesic approach for thoracic surgery. It also seeks to provide clinical guidance for the implementation of opioid-free or reduced-opioid postoperative analgesia in other thoracic procedures, aiming to optimize postoperative pain management for patients and ultimately enhance the overall patients recovery experience.

Conditions

Postoperative Pain

Keywords

Lung Cancer; Postoperative pain; OFA; Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative 48-h analgesic efficacy at cough

  The primary outcome is to compare the overall postoperative 48-h analgesic efficacy with cough as indicated by the cumulative area under curve (AUC) for the NRS over the 48-h period using the trapezoidal rule;

  Leave the PACU (T0), postoperative 6 hours (T1)、postoperative 12 hours (T2)、 postoperative 24 hours (T3)、 postoperative 36 hours (T4) and postoperative 48 hours (T5).

Secondary Outcomes (10)

• Postoperative 48-h analgesic efficacy at rest

  Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .

• Postoperative quality of recovery

  Postoperative 24 hours 、postoperative 48 hours

• Postoperative pulmonary complications

  From the time of leaving the PACU until the time of the first occurrence of pulmonary complications or the time of death from any cause, whichever came first, assessed up to 30 days.

• The 48-hour postoperative rescue analgesia rate

  First 48 hours postoperatively

• Postoperative analgesic failure

  First 48 hours postoperatively

Study Arms (2)

ESPB Group

EXPERIMENTAL

The drug composition of the analgesic pump for erector spinae block was 300 mL of 0.25% ropivacaine, the mode was intermittent pumping, and the parameters were set as follows: 30 mL of the first dose, 5 mL/h of the background dose, and 10 mL of the pumping every 6h for the first 24 hours after the operation.

Drug: Ropivacaine

Convention group

ACTIVE COMPARATOR

Intravenous analgesic is sufentanil ( 2.0 μg/kg), 0.9% saline diluted to 100 mL, background dose of 2 ml/h, no loading dose, activated after extubation and continued until 48 hours postoperatively.

Drug: Sufentanil

Interventions

Ropivacaine DRUG

300 mL of 0.25% ropivacaine, the mode was intermittent pumping, and the parameters were set as follows: 30 mL of the first dose, 5 mL/h of the background dose, and 10 mL of the pumping every 6h for the first 24 hours after the operation.

Also known as: Erector spinae plane block

ESPB Group

Sufentanil DRUG

Sufentanil 2.0 μg/kg, 0.9% saline diluted to 100 mL, background dose of 2 ml/h, no loading dose, activated after extubation and continued until 48 hours postoperatively.

Also known as: Intravenous analgesia

Convention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years.
• Patients with lung cancer or suspected lung cancer who are undergoing lobectomy surgery via Video-assisted thoracoscopic surgery (VATS) or Robotic-assisted thoracoscopic surgery (RATS).
• American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ.
• Surgery is expected to last at least 2 hours, with a minimum of 2 days of postoperative hospitalization.
• Patients participate voluntarily and have signed an informed consent form.

You may not qualify if:

• Patients who underwent open-heart surgery.
• Patients with BMI ≥30 kg/m², or ≤18.5 kg/m².
• Patients who are allergic to any of the local anesthetic drugs, such as ropivacaine, lidocaine, bupivacaine, procaine, bupivacaine, benzocaine, dacronin, etc.
• Patients who are allergic to any of the general anesthesia drugs, such as those including propofol, sufentanil, remifentanil, etc.
• Patients who currently have active ulcers or have gastrointestinal bleeding or who are allergic to any NSAIDs such as parecoxib sodium, flurbiprofenol ester, and acetaminophen.
• Patients with contraindications to epidural spinal plane block (ESPB), such as skin infection near the puncture site or coagulation disorders.
• Patients allergic to ultrasound gel.
• Patients with significant preoperative renal insufficiency (creatinine more than twice the upper limit of normal).
• Patients with severe spinal deformities prior to surgery.
• Patients with preoperative distant tumor metastasis.
• Patients who have experienced cardiovascular or cerebrovascular accidents within the past six months.
• Patients with unstable angina, ischemic myocardial infarction, or heart failure in the last six months.
• Patients with severe preoperative lung disease (such as pulmonary fibrosis, severe lung abscess, pulmonary heart disease; or with FEV1 less than 50% of the predicted value, PaO2 ≤ 60 mmHg, PaCO2 \> 50 mmHg).
• Patients with poorly controlled preoperative hypertension or diabetes mellitus.
• Patients with a past history of dementia, psychosis, or other neurological disorders.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

MeSH Terms

Conditions

Pain, Postoperative; Lung Neoplasms

Interventions

Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Junqiang Hu, bachelor

CONTACT

17702007842; 3336862127@qq.com

Yonghua Yao, master

CONTACT

13711568864; yaoyonghua01@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In view of ethical considerations, the study was not blinded to anesthesiologists and patients, and the investigator responsible for postoperative follow-up was not involved in intraoperative anesthesia management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share