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

NCT06819748 | Recruiting

• 1 other identifier: 20247411
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy, Laparoscopic; Ambulatory Surgical Procedures; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Opioid Administration

  2, 6, 12, 24 hours postoperatively

Study Arms (2)

A group

EXPERIMENTAL

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

B group

ACTIVE COMPARATOR

Drug: 0.5%ropivacaine

Drug: 0.5% ropivacaine

Interventions

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

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

Also known as: 0.5% ropivacaine, The cocktail of ropivacaine

A group

0.5% ropivacaine DRUG

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

B group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Ropivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dan Fan, M.D/PhD

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Liu

CONTACT

86-18980704707; 364876168@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 14, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)