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Clinical Trials in China / NCT06819748
Recruiting Not applicable

Efficacy and Safety of Cocktail of Ropivacaine for Local Infiltration Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

NCT06819748 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Provincial People's Hospital
Phase
Not applicable
Started
2025-02-14
Last updated
2025-02-19

Condition(s) studied

Cholecystectomy, LaparoscopicAmbulatory Surgical ProceduresMultimodal Analgesia

Investigational drug(s) / intervention(s)

The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone0.5% ropivacaine

The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone: The patient receive the cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone as incision local anesthesia at the end of surgery

0.5% ropivacaine: The patient receive 0.5% ropivacaine as incision local anesthesia at the end of surgery

Study summary

The goal of this clinical trial is to learn if the use of cocktail of ropivacaine,sodium bicarbonate and dexamethasone for incision local infiltration analgesia in patients undergoing ambulatory laparoscopic cholecystectomy is safe and effective. The main questions it aims to answer are:

Does the cocktail lower the The incidence of moderate to severe pain during movement stages within six hours after surgery.

Researchers will compare the cocktail to ropivacaine for incision local infiltration analgesia to see if the cocktail works to moderate the postoperative pain of ambulatory laparoscopic cholecystectomy patients.

Participants will:

Receive the cocktail or ropivacaine for incision local infiltration analgesia at the end of the surgery.

Answer the questions about postsurgical pain at rest or during motion(using a Numeric Rating Scale (NRS) of 0 to 10. Pain measurements were performed at 2, 6, 12, 24 hours,3,7,30 days and 3 months postoperatively.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients undergoing daytime laparoscopic cholecystectomy in Sichuan Provincial People's hospital ② Age: 18-70 years * American society of Anesthesiologists physical status classification system I-II ④ 18 kg/㎡≤ BMI ≤ 30 kg/㎡ ⑤ No communication barriers, able to understand the research process and the use of pain scale. * Signed informed consent Exclusion Criteria: * Drug allergy related to this study * History of chronic pain, long-term use of analgesic drugs (equivalent to ≥ 10mg oxycodone per day), alcohol abuse, gastrointestinal bleeding or perforation after application of non steroidal anti-inflammatory drugs * Patients with ischemic heart disease, peripheral arterial vascular or cerebrovascular disease, or patients with pulmonary heart disease, active peptic ulcer or gastrointestinal bleeding, or patients with inflammatory bowel disease * Patients taking monoamine oxidase inhibitors or within 2 weeks after discontinuation ⑤ Preoperative pain score (NRS ) was greater than or equal to 4 points ⑥ Participated in other clinical studies within three months

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819748 on ClinicalTrials.gov ↗ ← All trials in China