Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

NCT02649179 | Completed DMC

• 1 other identifier: XJH-A-ESR-14-10228
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

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

  0-24h postoperative

Study Arms (2)

local infiltration with ropivacaine

EXPERIMENTAL

patients were to receive 0.75% ropivacaine

Drug: Ropivacaine

local infiltration with 0.9% saline

PLACEBO COMPARATOR

patients were to receive placebo

Drug: 0.9% saline

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

local infiltration with ropivacaine

0.9% saline DRUG

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.

Also known as: saline

local infiltration with 0.9% saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhihong Lu, MD

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)