Using a pain relief cocktail for patients having laparoscopic gallbladder surgery

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

This study is testing a new pain relief mix for patients having gallbladder surgery to see if it helps reduce pain after the operation compared to using just one of the ingredients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sichuan Provincial People's Hospital (other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06819748 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of a cocktail consisting of ropivacaine, sodium bicarbonate, and dexamethasone for local infiltration analgesia in patients undergoing ambulatory laparoscopic cholecystectomy. Researchers will compare this cocktail to ropivacaine alone to determine if it reduces moderate to severe pain during movement in the first six hours post-surgery. Participants will receive the treatment at the end of their surgery and report their pain levels at various intervals using a Numeric Rating Scale. The study is conducted at Sichuan Provincial People's Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 undergoing daytime laparoscopic cholecystectomy with a BMI between 18 and 30.

Not a fit: Patients with drug allergies related to the study, chronic pain conditions, or significant cardiovascular or gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve postoperative pain management for patients undergoing laparoscopic cholecystectomy.

How similar studies have performed: While similar approaches to pain management have been explored, the specific combination of this cocktail for laparoscopic cholecystectomy is relatively novel.

Eligibility criteria

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

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Dan Fan, M.D/PhD — Sichuan Provincial People's Hospital
• Study coordinator: Yue Liu

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