## Protocol Section
### Identification Module
**NCT ID:** NCT02649179

**Brief Title:** Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

**Official Title:** Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Placebo Controlled, Double-blind Trial

#### Organization Study ID Info
**ID:** XJH-A-ESR-14-10228
#### Organization
**Class:** OTHER
**Full Name:** Air Force Military Medical University, China
### Status Module
#### Completion Date
**Date:** 2017-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-26

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Start Date
**Date:** 2016-08

**Type:** ACTUAL

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2016-01-07
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-06
**Study First Submit QC Date:** 2016-01-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Air Force Military Medical University, China

#### Responsible Party

**Investigator Affiliation:** Air Force Military Medical University, China

**Investigator Full Name:** Zhihong LU

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline).

**Detailed Description:** Patients were randomly assigned to two groups, On Day 1,each subject was to undergo laparoscopic cholecystectomy under general anesthesia. Anesthesia will be induced with fentanly (2-4ug/kg), propofol TCI (4ug/ml), rocuronium (0.6mg/kg), and maintaine with remifentanly(0.1-0.3ug/kg.h) , and propofol TCI (3-5ug/ml). At the end of the operation before wound closure, patients were randomized 1:1 to receive ropivacaine or placebo. In study group all wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. All anesthetics will be stopped when wound infiltration completed. Patients will be send to PACU for monitor a while then back to ward. Record of pain intensity evaluation and rescue analgesic medication consumption were to continue through 48hours after administration of study drug. Pain intensity will be assessed by using a 0-10 point VAS scale. VAS-rest and VAS-coughing were recorded at the baseline ,2,4,6,8,12,18,24,48 hours. Postoperative Rescue analgesia consisit of Parecoxib Sodium 40mg be given by a nurse on requst of the subject to a maximum of 80mg per day.

### Conditions Module

**Conditions:**

- Postoperative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 140

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients were to receive 0.75% ropivacaine

**Intervention Names:**

- Drug: Ropivacaine

**Label:** local infiltration with ropivacaine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** patients were to receive placebo

**Intervention Names:**

- Drug: 0.9% saline

**Label:** local infiltration with 0.9% saline

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- local infiltration with ropivacaine

**Description:** All wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.

**Name:** Ropivacaine

**Other Names:**

- Naropin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- local infiltration with 0.9% saline

**Description:** All wounds were infiltrated with 0.9% saline 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.

**Name:** 0.9% saline

**Other Names:**

- saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative

**Time Frame:** 0-24h postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female or male, and any race, Age≥18 years at the screening visite.
* ASA physical status I to II.
* Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
* Famale subjects must be without pregnancy.
* Ability to provide informed consent, adhere to the study visite schedule, and complete all study assessments.

Exclusion Criteria:

* Boss mass index \>35kg/㎡
* Under intravertebral anesthesia and/or epidural analgesia
* Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA).
* Inability to understand and use the visual analog scale (VAS)
* Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration.
* Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3months,or non-opioid pain medications more than 5 times per week.
* Proven or suspected allergy to local anesthetics ,NSAIDs and opioids .
* Use of any NSAIDs including selective COX-2 inhibitor , opioids or other analgesic agents within 3days of surgery.
* History of suspected or known addiction to or abuse of drugs or alcohol within the past 2 years.
* Current acute or chronic medical or major psychiatric disease that,in the opinion of the investigator ,would interfere with the evaluation of study drug efficacy or safety.
* Any other subjects were not suitable to this study in the opinion of the investigator.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Xi'an

**Country:** China

**Facility:** Xijing Hospital, Fourth Military Medical University

**State:** Shaanxi

**Zip:** 710032

#### Overall Officials

**Official 1:**

**Affiliation:** Air Force Military Medical University, China

**Name:** Zhihong Lu, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1700

- Name: Ropivacaine

- Relevance: HIGH

- As Found: Eye

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077212

- Term: Ropivacaine

### Misc Info Module

- Version Holder: 2024-05-24
