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Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine
0.9% saline
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

local infiltration with ropivacaine

local infiltration with 0.9% saline

Arm Description

patients were to receive 0.75% ropivacaine

patients were to receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
July 25, 2018
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local infiltration with ropivacaine
Arm Type
Experimental
Arm Description
patients were to receive 0.75% ropivacaine
Arm Title
local infiltration with 0.9% saline
Arm Type
Placebo Comparator
Arm Description
patients were to receive placebo
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
saline
Intervention 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.
Primary Outcome Measure Information:
Title
The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative
Time Frame
0-24h postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Lu, MD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

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