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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ESPB GroupExperimental treatment 1 intervention
Group B: Convention groupActive comparator 1 intervention

Trial outcomes

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;

Time frame
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

1

Postoperative 48-h analgesic efficacy at rest

Compare the overall postoperative 48-h analgesic efficacy at rest as indicated by the cumulative area under curve (AUC) for the NRS over the 48-h period using the trapezoidal rule;

Time frame
Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .
2

Postoperative quality of recovery

Quality of recovery-15 (QoR-15) over the first postoperative 24 and 48 hours.

Time frame
Postoperative 24 hours 、postoperative 48 hours
3

Postoperative pulmonary complications

Postoperative pulmonary complications are defined as a series of respiratory abnormalities that occur in patients after thoracoscopically assisted lobectomy. These complications may include, but are not limited to: prolonged oxygenation, pulmonary atelectasis, respiratory failure, ARDS, postoperative pneumonia, pleural effusion, pneumothorax, bronchospasm, aspiration pneumonia, and unplanned new or prolonged invasive mechanical ventilation.

Time frame
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.
4

The 48-hour postoperative rescue analgesia rate

The 48-hour postoperative rescue analgesia rate was defined as the percentage of patients requiring additional analgesic medication due to inadequate pain control (NRS score ≥4 at rest) during the 48-hour postoperative period as a proportion of the total number of patients in the group.

Time frame
First 48 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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