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

NCT ID: NCT06819748

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-14

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cholecystectomy, Laparoscopic Ambulatory Surgical Procedures Multimodal Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A group

Drug:cocktail of 0.5% ropivacaine ,5%sodium bicarbonate and 10mg dexamethasone

Group Type EXPERIMENTAL

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

Intervention Type 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

B group

Drug: 0.5%ropivacaine

Group Type ACTIVE_COMPARATOR

0.5% ropivacaine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

0.5% ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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0.5% ropivacaine The cocktail of ropivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xia Zhiying

resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Fan, M.D/PhD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Locations

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Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Liu

Role: CONTACT

86-18980704707

Facility Contacts

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Dan Fan, PhD/M.D.

Role: primary

8617708130205

Other Identifiers

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20247411

Identifier Type: -

Identifier Source: org_study_id

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