NCT06819748 Efficacy and Safety of Cocktail of Ropivacaine for Local Infiltration Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
| NCT ID | NCT06819748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sichuan Provincial People's Hospital |
| Condition | Cholecystectomy, Laparoscopic |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-02-14 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Dan Fan, M.D/PhD
PRINCIPAL INVESTIGATOR
Sichuan Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06819748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cholecystectomy, Laparoscopic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06819748 currently recruiting?
Yes, NCT06819748 is actively recruiting participants. Contact the research team at 364876168@qq.com for enrollment information.
Where is the NCT06819748 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06819748 clinical trial?
NCT06819748 is sponsored by Sichuan Provincial People's Hospital. The principal investigator is Dan Fan, M.D/PhD at Sichuan Provincial People's Hospital. The trial plans to enroll 210 participants.