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

NCT02777866 | Unknown DMC

• 1 other identifier: CIBH-1566
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Postoperative Surgical Site Infection (SSI) defined by the Centre for Disease Control (CDC) criteria

  Postoperative surgical site infection (SSI), as defined by the following Centre for Disease Control (CDC) criteria: Infection occurring within the first 30 post-operative days with at least one of the following: 1. Purulent drainage from the incision 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision 3. At least one of the following signs/symptoms of infection * Pain or tenderness * Localized swelling * Redness * Heat AND incision is deliberately opened by a surgeon (unless incision is culture negative) 4. Diagnosis of SSI by the surgeon or attending physician

  30 days following operation

• Efficacy of 0.5% Bupivacaine Infiltration for Post-op Pain measured using a Numeric Scale; 0-10

  Measurement of the efficacy of 0.5% Bupivacaine wound infiltration for the treatment of postoperative pain as measured by patient pain intensity (Numeric Scale; 0-10).

  Baseline to 48 hours postoperative

Study Arms (2)

1: Bupivacaine 0.5%

EXPERIMENTAL

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: Infiltration of 0.5% Bupivacaine

2: 0.9% Saline Solution

PLACEBO COMPARATOR

Patients who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs, who will be infiltrated in the total thickness of the abdominal wall with 0.9% Saline Solution, every 1 cm, on each side of the surgical wound.

Drug: Placebo: Infiltration of 0.9% Saline Solution

Interventions

Infiltration of 0.5% Bupivacaine DRUG

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

1: Bupivacaine 0.5%

Placebo: Infiltration of 0.9% Saline Solution DRUG

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

2: 0.9% Saline Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are planned to a elective gastrointestinal surgery.
• Biliary-pancreatic open procedures: biliodigestive Derivation, Pancreatoduodenectomy, Pancreato-jejunostomy (Puestow procedure, Frey).
• Open upper gastrointestinal procedures: total gastrectomy, subtotal gastrectomy (distal gastrectomy with Billroth I reconstruction or Billroth II or Roux-Y), Gastro-jejunum anastomosis, Open gastro-jejunal Roux Y bypass, intestinal resection, intestinal reconnection, intestinal Fistulectomy.
• Open colorectal procedures: Right or Left Hemicolectomy, total colectomy, low anterior resection, abdominal-perineal resection.
• Patients who decide signing the informed consent after explained the study.
• Patients with postoperative follow-up of at least 30 days, in whom the wound and / or local complications will be evaluated.

You may not qualify if:

• Patients operated laparoscopically.
• Patients operated at another hospital.
• Patients with clean surgical wounds.
• Patients in whom an epidural or subarachnoid block is used.
• Patients who are unable to sign the informed consent.
• Patients with less than 50 kg.
• Patients wiht history of: Malignant hyperthermia, cardiac disease (Heart failure, history of myocardial infarction, arrhythmias), Epilepsy, Allergic to amides.
• Patients with incomplete follow-up (less than 30 days).
• Pregnant patients.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tlalpan, Mexico City, Mexico City, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Noel Salgado-Nesme

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noel Salgado-Nesme, MD

CONTACT

+52(55)54870900; noelsalgadonesme@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: May 19, 2016

Record last verified: 2016-04

Locations

ME (1)