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

Not Applicable

Recruiting

• Conditions: Cholecystectomy, Laparoscopic; Ambulatory Surgical Procedures; Multimodal Analgesia
• Interventions: Drug: The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone; Drug: 0.5% ropivacaine

• Registration Number: NCT06819748
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Study Start: 2025-02-14
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group	The cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10 mg dexamethasone	Drug:cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10mg dexamethasone
B group	0.5% ropivacaine	Drug: 0.5%ropivacaine

Primary Outcome Measures

Name	Time	Method
The incidence of moderate to severe pain（Numerical Rating Scale) during movement stages within six hours after surgery	2, 6, 12, 24 hours,3,7,30 days and 3 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Opioid Administration	2, 6, 12, 24 hours postoperatively	The administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China