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

N/ARecruitingNCT06819748

Sichuan Provincial People's Hospital210 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

210

Conditions

Cholecystectomy, Laparoscopic Ambulatory Surgical Procedures Multimodal Analgesia

Interventions

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

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% ropivacaineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of moderate to severe pain（Numerical Rating Scale) during movement stages within six hours after surgery

The result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points. Acute pain is labeled of a value ≥4 points.

Time frame: 2, 6, 12, 24 hours,3,7,30 days and 3 months postoperatively

Secondary Outcomes

Number of Participants With Opioid Administration

The administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.

Time frame: 2, 6, 12, 24 hours postoperatively