Efficacy and Safety of Cocktail of Ropivacaine for Local Infiltration Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone, 0.5% ropivacaine.
- Who it may be relevant to
- Registry conditions: Cholecystectomy, Laparoscopic, Ambulatory Surgical Procedures, Multimodal Analgesia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Cocktail of Ropivacaine,sodium Bicarbonate and Dexamethasone for Incision Local Infiltration Analgesia in Patients Undergoing Ambulatory Laparoscopic Cholecystectomy:A Prospective Randomized Control Trial
Overview
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.
Interventions
- Drug 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 - Drug 0.5% ropivacaine
The patient receive 0.5% ropivacaine as incision local anesthesia at the end of surgery
Primary outcome measures
- The incidence of moderate to severe pain（Numerical Rating Scale) during movement stages within six hours after surgery [Time frame: 2, 6, 12, 24 hours,3,7,30 days and 3 months postoperatively]
Secondary outcome measures (1)
- Number of Participants With Opioid Administration [Time frame: 2, 6, 12, 24 hours 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sichuan Provincial People's Hospital — Chengdu
Identifiers
NCT: NCT06819748 · 20247411