Postoperative PainEarly Phase 1NCT06570538
Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy
A Early Phase 1 study testing Ropivacaine and Sufentanil in people with Postoperative Pain, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Early Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Patients undergoing concurrent treatment for other surgical conditions.
- Patients taking sedatives, antidepressants, or hormonal medications.
- Patients with chronic pain, alcoholism, or drug dependence.
- Patients who are pregnant or breastfeeding
- Patients with other potentially serious medical conditions.
- Patients who are unable to understand Mandarin or Cantonese.
- Patients who participated in other clinical trials in the past 3 months
- Patients who refuse to participate in the study or sign the informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy: an Open-label, Randomized, Controlled, Non-inferiority 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.
Read the detailed description
Patients who undergo thoracoscopic lobectomy are often at an elevated risk of opioid-related complications due to their reliance on opioids. This overdependence not only decelerates the postoperative recovery process but also significantly increases healthcare costs. Although there is a surge of interest in opioid-free anesthetic analgesia (OFA) for its potential to reduce adverse outcomes associated with opioid use, there is a dearth of randomized controlled trials examining the efficacy of postoperative analgesia in patients undergoing thoracoscopic surgery. Consequently, the actual effectiveness of OFA in improving postoperative pulmonary complications and facilitating patient recovery remains unclear. Its application is still in the exploratory phase, with clinical practice lacking definitive guidelines to endorse or discard OFA as an alternative for postoperative analgesia in thoracoscopic surgery.
To bridge this knowledge gap and evaluate the perioperative analgesic efficacy of OFA compared to traditionally used opioids in selected cancer patients undergoing thoracoscopic surgery, 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 patient recovery experience.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine, Sufentanil
- Keywords
- Lung Cancer, Postoperative pain, OFA, Erector spinae plane block
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Erector spinae plane block
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.
SufentanilDrug
Also called Intravenous analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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
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;
Measured: Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .
Postoperative quality of recovery
Quality of recovery-15 (QoR-15) over the first postoperative 24 and 48 hours.
Measured: Postoperative 24 hours 、postoperative 48 hours
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.
Measured: 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
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.
Measured: First 48 hours postoperatively
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.
Measured: First 48 hours postoperatively
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
Measured: First 48 hours postoperatively
Time to resume
The time to off-bed, bowel movement, and oral intake.( measured in days)
Measured: 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.
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.
Measured: 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.
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.
Measured: Of the time from leaving the PACU to the time of postoperative 90day.
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.
Measured: First 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570538
- Sponsor's protocol ID
- ATHGuangzhou.
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy: an Open-label, Randomized, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06570538
- Acronym / sponsor ID
- ATHGuangzhou.
- Conditions
- Postoperative Pain
- Keywords
- Lung Cancer, Postoperative pain, OFA, Erector spinae plane block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who undergo thoracoscopic lobectomy are often at an elevated risk of opioid-related complications due to their reliance on opioids. This overdependence not only decelerates the postoperative recovery process but also significantly increases healthcare costs. Although there is a surge of interest in opioid-free anesthetic analgesia (OFA) for its potential to reduce adverse outcomes associated with opioid use, there is a dearth of randomized controlled trials examining the efficacy of postoperative analgesia in patients undergoing thoracoscopic surgery. Consequently, the actual effectiveness of OFA in improving postoperative pulmonary complications and facilitating patient recovery remains unclear. Its application is still in the exploratory phase, with clinical practice lacking definitive guidelines to endorse or discard OFA as an alternative for postoperative analgesia in thoracoscopic surgery.
To bridge this knowledge gap and evaluate the perioperative analgesic efficacy of OFA compared to traditionally used opioids in selected cancer patients undergoing thoracoscopic surgery, 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 patient recovery experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Experimental | Drug: RopivacaineThe 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. |
| Convention group | Active comparator | Drug: SufentanilIntravenous 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Erector spinae plane block300 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 | ESPB Group |
| SufentanilAlso: Intravenous analgesiaSufentanil 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 | Convention group |
Primary outcome
Postoperative 48-h analgesic efficacy at cough
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).
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;
10 secondary outcomes
Postoperative 48-h analgesic efficacy at rest
Time frame: Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .
Postoperative quality of recovery
Time frame: Postoperative 24 hours 、postoperative 48 hours
Postoperative pulmonary complications
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.
The 48-hour postoperative rescue analgesia rate
Time frame: First 48 hours postoperatively
Postoperative analgesic failure
Time frame: First 48 hours postoperatively
Patient satisfaction with postoperative pain ratings
Time frame: First 48 hours postoperatively
Time to resume
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.
The incidence of unplanned ICU admission and reoperation
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.
The 30d- and 90d- mortality
Time frame: Of the time from leaving the PACU to the time of postoperative 90day.
Related Adverse Events
Time frame: First 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ropivacaine and Sufentanil in people with Postoperative Pain, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junqiang Hu, bachelor (17702007842, 3336862127@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 48-h analgesic efficacy at cough (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.