MedTrace Logo

LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures

NCT02777866 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2016-05-19

No results posted yet for this study

Summary

The purpose of this study is to determine if the infiltration of 0.5% Bupivacaine in the surgical wound is effective to diminish the pain and the risk of surgical site infections in patients who go to a open gastrointestinal procedure.

Conditions

  • Surgical Site Infection
  • Wound Infection
  • Postoperative Pain
  • Local Anesthetics

Interventions

DRUG

Infiltration of 0.5% Bupivacaine

Patients who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs (bile duct, stomach, small bowel or colon), who will be infiltrated in the total thickness of the abdominal wall (Peritoneum-muscle fascia- Subcutaneous tissue) with 0.5% Bupivacaine, every 1 cm, on each side of the surgical wound

DRUG

Placebo: Infiltration of 0.9% Saline Solution

Patients who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs (bile duct, stomach, small bowel or colon), who will be infiltrated in the total thickness of the abdominal wall (Peritoneum-muscle fascia- Subcutaneous tissue) with 0.9% Saline Solution, every 1 cm, on each side of the surgical wound

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Noel Salgado-Nesme · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-01-31

Countries

  • Mexico

More Related Trials

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 NCT02777866 on ClinicalTrials.gov