Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy

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 Overview

• Status: Not yet recruiting
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: Paracetamol and Mannitol Injection; Drug: Parecoxib

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JianHong Xu; Phone Number: 86-18867961109; Email: xujh1969@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Obtain informed consent；
2. Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
3. Classified as American Society of Anesthesiologists (ASA) physical status I~II；
4. Age over 18 years；
5. Patients voluntarily participate and sign the informed consent form

Exclusion Criteria:

1. Systolic blood pressure ≥180 mm Hg or <90 mm Hg, diastolic blood pressure ≥110 mm Hg or <60 mmHg
2. heart rate <50 beats/min；
3. 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
4. severe kidney dysfunction: creatinine clearance <60 ml/min)；
5. Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
6. Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease；
7. History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse；
8. Neuromuscular diseases；
9. Tendency towards malignant hyperthermia；
10. Allergy to the study drug or other contraindications；
11. Participation in another drug clinical trial within the past 30 days；
12. Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months；
13. Unstable angina, myocardial infarction in the last 3 months；
14. Undergone another surgery within the last 3 months；
15. Coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol and Mannitol Injection group; Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation	Drug: Paracetamol and Mannitol Injection; Paracetamol and Mannitol Injection 500mg; Other Names: Acetaminophen Mannitol Injection
Active Comparator: Parecoxib group; 40mg of parecoxib was given intravenously 30min before the end of the operation	Drug: Parecoxib; 40mg of parecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	after extubation 10 (±5) minutes and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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)	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)	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)	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)	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: thoracic surgery; postoperative analgesia; Paracetamol and Mannitol Injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Cyclooxygenase 2 Inhibitors; Mannitol; Acetaminophen; Parecoxib
• Other Study ID Numbers: KY-2023-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No