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

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Liu; Phone Number: 86-18980704707; Email: 364876168@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Dan Fan, PhD/M.D.; Phone Number: 8617708130205; Email: fandan1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group; Drug:cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10mg dexamethasone	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; Other Names: 0.5% ropivacaine; The cocktail of ropivacaine
Active Comparator: B group; Drug: 0.5%ropivacaine	Drug: 0.5% ropivacaine; The patient receive 0.5% ropivacaine as incision local anesthesia at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 6, 12, 24 hours,3,7,30 days and 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 6, 12, 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Principal Investigator: Dan Fan, M.D/PhD, Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Dexamethasone
• Other Study ID Numbers: 20247411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No