|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02223533 |
|
Date of registration:
|
18/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial
|
|
Scientific title:
|
Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial. |
|
Date of first enrolment:
|
January 2012 |
|
Target sample size:
|
110 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02223533 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Sorkunde Telletxea, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Galdakao-Usansolo |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients were eligible for the study if they were aged 18 years or older, with an
American Society of Anesthesiologists (ASA) 14 grade of I to IV (anaesthetic risk),
were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to
participate by signing an informed consent form.
Exclusion Criteria:
- Patients were excluded if they were allergic to amides or pyrazolones, were likely to
require conversion to open surgery with laparotomy, were long-term users of opioids,
required emergency surgery, were unable to participate due to cognitive
deterioration, or declined to participate in the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain
|
|
Intervention(s)
|
|
Drug: morphine
|
|
Device: 19Gx500-mm Pajunk InfiltraLong® catheter
|
|
Primary Outcome(s)
|
|
Assessment of intravenous morphine consumption after laparoscopic colon surgery
[Time Frame: Over the 48 hours after laparoscopic colon surgery]
|
|
Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration
[Time Frame: Over the 48 hours after laparoscopic colon surgery]
|
|
Secondary Outcome(s)
|
|
Complications related to intravenous morphine consumption
[Time Frame: Over the 48 hours after laparoscopic colon surgery]
|
|
Secondary ID(s)
|
|
sork-2011111058
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|