Postoperative AnalgesiaNCT06304181
Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy
A study testing Paracetamol and Mannitol Injection and Parecoxib in people with Postoperative Analgesia, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Paracetamol and Mannitol Injection and Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 30 Dec 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obtain informed consent；
- Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
- Classified as American Society of Anesthesiologists (ASA) physical status I~II；
- Age over 18 years；
- Patients voluntarily participate and sign the informed consent form
Who cannot join
- Systolic blood pressure ≥180 mm Hg or <90 mm Hg, diastolic blood pressure ≥110 mm Hg or <60 mmHg
- heart rate <50 beats/min；
- Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one >2 times the upper limit of normal
- severe kidney dysfunction: creatinine clearance <60 ml/min)；
- Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
- Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease；
Show all 15Show fewer
- History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse；
- Neuromuscular diseases；
- Tendency towards malignant hyperthermia；
- Allergy to the study drug or other contraindications；
- Participation in another drug clinical trial within the past 30 days；
- Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months；
- Unstable angina, myocardial infarction in the last 3 months；
- Undergone another surgery within the last 3 months；
- Coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.
- Conditions
- Postoperative Analgesia
- Being tested
- Paracetamol and Mannitol Injection, Parecoxib
- Keywords
- Paracetamol and Mannitol Injection, postoperative analgesia, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and Mannitol InjectionDrug
Also called Acetaminophen Mannitol Injection
Paracetamol and Mannitol Injection 500mg
ParecoxibDrug
40mg of parecoxib
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol and Mannitol Injection group | Experimental | Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation Receives: Drug: Paracetamol and Mannitol Injection |
| Parecoxib group | Active comparator | 40mg of parecoxib was given intravenously 30min before the end of the operation Receives: Drug: Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS scores
NRS scores at rest and during movement (coughing) after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
Measured: after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
RASS score
RASS score after extubation 10 (±5) minutes and 24 hours after surgery
Measured: after extubation 10 (±5) minutes and 24 hours after surgery
Secondary outcomes (8)
Time of first use of remedial analgesics or analgesic pump
Time of first use of remedial analgesics or analgesic pump after surgery,assessed up to 3 days
Measured: From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days
Total analgesic pump drug use
The total drug use of analgesic pump was recorded during follow-up
Measured: From the end of surgery until removal of the analgesic pump,assessed up to 3 days
Postoperative liver enzyme level
Measurement of level of liver enzymes in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative bilirubin level
Measurement of level of bilirubin in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative creatinine level
Measurement of level of creatinine in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative cortisol level
Measurement of level of ccortisol in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-6 level
Measurement of level of IL-6 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-8 level
Measurement of level of IL-8 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Measured: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304181
- Sponsor's protocol ID
- KY-2023-195
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT06304181
- Acronym / sponsor ID
- KY-2023-195
- Conditions
- Postoperative Analgesia
- Keywords
- Paracetamol and Mannitol Injection, postoperative analgesia, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Mar 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.
This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol and Mannitol Injection group | Experimental | Drug: Paracetamol and Mannitol InjectionParacetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation |
| Parecoxib group | Active comparator | Drug: Parecoxib40mg of parecoxib was given intravenously 30min before the end of the operation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obtain informed consent；
- Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
- Classified as American Society of Anesthesiologists (ASA) physical status I~II；
- Age over 18 years；
- Patients voluntarily participate and sign the informed consent form
Key exclusion criteria (15 listed)
- Systolic blood pressure ≥180 mm Hg or <90 mm Hg, diastolic blood pressure ≥110 mm Hg or <60 mmHg
- heart rate <50 beats/min；
- Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one >2 times the upper limit of normal
- severe kidney dysfunction: creatinine clearance <60 ml/min)；
- Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
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 |
|---|---|---|
| Paracetamol and Mannitol InjectionAlso: Acetaminophen Mannitol InjectionParacetamol and Mannitol Injection 500mg | Drug | Paracetamol and Mannitol Injection group |
| Parecoxib40mg of parecoxib | Drug | Parecoxib group |
Primary outcome
NRS scores
Time frame: after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
NRS scores at rest and during movement (coughing) after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
RASS score
Time frame: after extubation 10 (±5) minutes and 24 hours after surgery
RASS score after extubation 10 (±5) minutes and 24 hours after surgery
8 secondary outcomes
Time of first use of remedial analgesics or analgesic pump
Time frame: From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days
Total analgesic pump drug use
Time frame: From the end of surgery until removal of the analgesic pump,assessed up to 3 days
Postoperative liver enzyme level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative bilirubin level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative creatinine level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative cortisol level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-6 level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-8 level
Time frame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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 study testing Paracetamol and Mannitol Injection and Parecoxib in people with Postoperative Analgesia, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 15 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 12 Mar 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.
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 JianHong Xu (86-18867961109, xujh1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS scores (time frame: after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery). The study lists 2 primary outcomes in all. 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 12 Mar 2024.