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

Browse trials for

• Pain, Postoperative 5,093

Keywords

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

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 140 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University is the lead sponsor of 28 studies on the registry; 15 are open to participants now.

Study arms

• Experimental
  ESPB Group

  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

• Active comparator
  Convention group

  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

• DrugRopivacaine

  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

• DrugSufentanil

  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

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

5. Postoperative analgesic failure

   Postoperative analgesic failure was defined as that during postoperative period, the patient uses a pain pump for pain control, and even after implementing rescue analgesic measures, the patient's resting NRS score remains ≥4, or the NRS score during activities (such as coughing) remains ≥7. This indicates that the pain control has not achieved the expected effect and is considered analgesia failure.

   Time frame: First 48 hours postoperatively

6. Patient satisfaction with postoperative pain ratings

   Patients' satisfaction with analgesic effect will be assessed using Likert scales, where 1 = extremely dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, and 5 = extremely satisfied

   Time frame: First 48 hours postoperatively

7. Time to resume

   The time to off-bed, bowel movement, and oral intake.( measured in days)

   Time frame: From the time of leaving the PACU until the time to off-bed, bowel movement, and oral intake or the time of death from any cause, whichever came first, assessed up to 7 days.

8. The incidence of unplanned ICU admission and reoperation

   The incidence of postoperative ICU admissions was defined as the number of patients requiring ICU transfer after surgery as a percentage of the total number of surgical patients over a given period of time. The incidence of reoperation was defined as the number of patients requiring additional surgery due to complications or other medical necessities arising after the initial surgery as a percentage of the total number of patients operated on during a given period of time.

   Time frame: From the time of leaving the PACU until the time to unplanned ICU admission or reoperation or the time of death from any cause, whichever came first, assessed up to 30 days.

9. The 30d- and 90d- mortality

   Postoperative 30-day mortality is usually defined as the percentage of patients who die from any cause within 30 days of surgery. This metric is often used to assess the risk of surgery and postoperative recovery. Postoperative 90-day mortality, on the other hand, refers to the proportion of patients who die from any cause within 90 days of surgery. This metric is also used to assess surgical outcomes and long-term patient recovery.

   Time frame: Of the time from leaving the PACU to the time of postoperative 90day.

10. Related Adverse Events

    ESPB-related adverse events and opioid-related adverse events ESPB-related adverse events: local infection, local hemorrhage, hematoma, pneumothorax, neurologic injury, local anesthetic toxicity, allergy, epidural anesthesia, total spinal anesthesia, palpitations, perioperative extubation, shock, and death. Opioid-related adverse events: postoperative respiratory depression, postoperative nausea and vomiting, postoperative delirium, postoperative constipation and intestinal obstruction, postoperative urinary retention, pruritus, drug abuse, and addiction.

    Time frame: First 48 hours postoperatively

Individual participant data

Plan to share: No