Actively Recruiting
Efficacy and Safety of Cocktail of Ropivacaine, Sodium Bicarbonate and Dexamethasone for Incision Local Infiltration Analgesia in Patients Undergoing Ambulatory Laparoscopic Cholecystectomy
Led by Sichuan Provincial People's Hospital · Updated on 2025-02-19
210
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if a mixture of ropivacaine, sodium bicarbonate, and dexamethasone used for local pain relief at the incision site is safe and effective in patients having outpatient laparoscopic gallbladder removal. The main question is whether this cocktail reduces moderate to severe pain during movement within six hours after surgery compared to using ropivacaine alone. Participants will receive either the cocktail or ropivacaine injected locally at the end of their surgery. The study groups include those receiving the combined cocktail and those receiving only ropivacaine. This is a randomized, triple-blind trial designed to compare the two treatments. Participants will be asked about their pain using a Numeric Rating Scale at rest and during movement at multiple times after surgery: 2, 6, 12, 24 hours, and then at 3, 7, 30 days, and 3 months. Researchers will also monitor if opioid pain medication is needed after surgery. The study monitors participants over several months to assess pain levels and treatment effects.
CONDITIONS
Brief Title
Efficacy and Safety of Cocktail of Ropivacaine for Local Infiltration Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing daytime laparoscopic cholecystectomy at Sichuan Provincial People's Hospital
- Age between 18 and 70 years
- Physical status classified as I or II by the American Society of Anesthesiologists
- Body Mass Index between 18 and 30 kg/m²
- Able to communicate and understand the research process and pain scale
- Signed informed consent form
You will not qualify if you...
- Allergy to any drugs used in this study
- History of chronic pain or long-term use of strong pain medications equivalent to 10 mg or more oxycodone per day
- Alcohol abuse
- History of gastrointestinal bleeding or perforation after using non-steroidal anti-inflammatory drugs
- Ischemic heart disease, peripheral arterial vascular disease, cerebrovascular disease, pulmonary heart disease
- Active peptic ulcer, gastrointestinal bleeding, or inflammatory bowel disease
- Use of monoamine oxidase inhibitors currently or within 2 weeks of stopping
- Preoperative pain score on Numeric Rating Scale of 4 or higher
- Participation in other clinical studies within the last three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo laparoscopic cholecystectomy and receive local infiltration analgesia with either the cocktail of ropivacaine, sodium bicarbonate, and dexamethasone or ropivacaine alone at the end of surgery.
1 visit (in-person) on the day of surgery
Duration - Up to 3 months after surgery
Participants are monitored for pain levels and opioid use at multiple timepoints after surgery.
Visits at 2, 6, 12, 24 hours and 3, 7, 30 days and 3 months postoperatively
Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Y
Yue Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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