Using a pain relief cocktail for patients having laparoscopic gallbladder surgery
Official title: 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
Run by Sichuan Provincial People's Hospital · NCT06819748 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | February 14, 2025 |
| Main results expected | June 1, 2025 |
| Study ends | September 1, 2025 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT06819748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 undergoing daytime laparoscopic cholecystectomy with a BMI between 18 and 30.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management for patients undergoing laparoscopic cholecystectomy.
How similar studies have gone: While similar approaches to pain management have been explored, the specific combination of this cocktail for laparoscopic cholecystectomy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: 364876168@qq.com
- Phone: 86-18980704707
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.