Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients
25. juli 2018 opdateret af: Zhihong LU, Air Force Military Medical University, China
Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Placebo Controlled, Double-blind Trial
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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710032
- Xijing hospital, Fourth military medical university
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: local infiltration with ropivacaine
patients were to receive 0.75% ropivacaine
|
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.
Andre navne:
|
|
Placebo komparator: local infiltration with 0.9% saline
patients were to receive placebo
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative
Tidsramme: 0-24h postoperative
|
0-24h postoperative
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: zhihong Lu, MD, Air Force Military Medical University, China
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2016
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
6. januar 2016
Først indsendt, der opfyldte QC-kriterier
6. januar 2016
Først opslået (Skøn)
7. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Smerter, postoperativ
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Bedøvelsesmidler, lokale
- Ropivacain
Andre undersøgelses-id-numre
- XJH-A-ESR-14-10228
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