Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06819748

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

Led by Sichuan Provincial People's Hospital · Updated on 2025-02-19

210

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing daytime laparoscopic cholecystectomy at Sichuan Provincial People's Hospital
  • Age between 18 and 70 years
  • American Society of Anesthesiologists physical status classification I or II
  • Body mass index (BMI) between 18 and 30 kg/m²
  • No communication barriers and able to understand the study and pain scale
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Allergy to any drugs used in this study
  • History of chronic pain or long-term use of analgesics equivalent to 10 mg or more oxycodone per day
  • Alcohol abuse
  • Gastrointestinal bleeding or perforation after using nonsteroidal anti-inflammatory drugs
  • Ischemic heart disease, peripheral arterial or cerebrovascular disease
  • Pulmonary heart disease
  • Active peptic ulcer or gastrointestinal bleeding
  • Inflammatory bowel disease
  • Use of monoamine oxidase inhibitors or discontinuation within 2 weeks
  • Preoperative pain score (NRS) of 4 or higher
  • Participation in other clinical studies within the last 3 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

Y

Yue Liu

CONTACT

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