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

NCT02223533 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2014-08-22

No results posted yet for this study

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

DEVICE

19Gx500-mm Pajunk InfiltraLong® catheter

Before 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.

DRUG

morphine

After the intervention patients had access to intravenous morphine via a patient-controlled analgesia

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Sorkunde Telletxea, MD, PhD · Hospital Galdakao-Usansolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2014-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223533 on ClinicalTrials.gov