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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | Drug:cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10mg dexamethasone |
|
| B group | Active Comparator | Drug: 0.5%ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Patients undergoing daytime laparoscopic cholecystectomy in Sichuan Provincial People's hospital â‘¡ 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.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Liu | Contact | 86-18980704707 | 364876168@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Fan, M.D/PhD | Sichuan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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|
| 0.5% ropivacaine | Drug | The patient receive 0.5% ropivacaine as incision local anesthesia at the end of surgery |
|
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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