Clinical Trials Directory

Trials / Completed

CompletedNCT02223533

Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial

Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
110 (actual)
Sponsor
Hospital Galdakao-Usansolo · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan can help control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital. Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and amount of intravenous morphine used via patient controlled infusion.

Conditions

Interventions

TypeNameDescription
DEVICE19Gx500-mm Pajunk InfiltraLong® catheterBefore completing the surgery, the surgical team inserted a 19Gx500-mm Pajunk InfiltraLong® catheter with multiple perforations in the last few centimeters before the tip to allow for local anesthetic administration.
DRUGmorphineAfter the intervention patients had access to intravenous morphine via a patient-controlled analgesia

Timeline

Start date
2012-01-01
Primary completion
2013-01-01
Completion
2014-01-01
First posted
2014-08-22
Last updated
2014-08-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02223533. Inclusion in this directory is not an endorsement.