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

Sichuan Provincial People's Hospital

Status: Enrolling

Conditions: Multimodal Analgesia; Ambulatory Surgical Procedures; Cholecystectomy, Laparoscopic

Treatments: Drug: 0.5% ropivacaine; Drug: The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06819748

20247411

Details and patient eligibility

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups

A group

Experimental group

Description:

Drug:cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10mg dexamethasone

Treatment:

Drug: The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone

B group

Active Comparator group

Description:

Drug: 0.5%ropivacaine

Treatment:

Drug: 0.5% ropivacaine