Surgical Site InfectionLAWNCT02777866
LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures
A study testing Infiltration of 0.5% Bupivacaine in people with Surgical Site Infection and Wound Infection, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Wound Infection, Postoperative Pain
- What is being tested?
- Infiltration of 0.5% Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteMexico
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Mexico City, Mexico City, 14000
Noel Salgado-Nesme, MD, +52(55)54870900 ext. 2140, noelsalgadonesme@yahoo.com.mx
About this study
Official title: LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures: A Blind Prospective Randomized Trial
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.
Read the detailed description
This is an experimental, randomized, prospective, double blind study, in which will compare two groups. First group of participants 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; Second group of participants 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.
In all participants undergoing to the protocol will make basic maneuvers to decreasing surgical site infection, which has already been standardized in the Institute. These maneuvers consist of administering prophylactic antibiotic 30 minutes before the incision, shaving of the abdominal wall with clipper in the OR, preoperative skin preparation with chlorhexidine gluconate 4%. All participants will get glucose control (<200 mg / dL), maintenance of the normothermia by putting hot air in the areas not exposed to the surgery field, heating fluids and getting intraoperative hyperoxia. Blood and components will be avoided as possible.
At the moment of closing of the abdominal wall, all the surgical personal will change the surgical gloves, also all the material that will be used should be sterile. The surgical nurse will pass the solution that will be injected, the investigator will not know the contents. 1 ml of the solution will be applied for each centimeter of the wound, covering the total thickness of the wall, on each side of the wound. After the closure of the fascia, the subcutaneous tissue will be washed with 1 liter of 0.9% saline solution. The skin will be closed with metal skin staples. The total administered dose of Bupivacaine should not be greater than stated as toxic (3mg/kg).
In all participants a 0.9% saline with 200 mg of Tramadol will be indicated for 24 hours. Participants may also receive IV Tramadol bolus of 25 mg, with a maximum of 4 in a day (top dose of 300 mg/day); in those participants in whom analgesia fails to control, the investigator may use other drugs like morphine of NSAIDs. No epidural or subarachnoid analgesia will be used.
All participants will be assessed 2 times per day for the presence of pain, this will be done with a numerical verbal scale from 0 to 10, when 0 is none pain, and 10 is the greatest pain that can reaches. The investigator will review the surgical wound once daily. The participant will be assessed every 7 days once discharged from hospital, in the outpatient clinic, until 30 days after the surgical procedure.
The sample size was calculated based on the incidence of surgical site infections in the Institute, which is 5%. The sample side required to demonstrate an expected reduction of 5% to 1%, with a power of 80% and a type 1 error of 5%, is 285 participants per group.
Randomization will be done electronically, which will be assigned 285 participants in each group.The investigators will annotate the number that will be given by the program in the participant expedient. The list of the numbers will be blind for investigators, and only the attending anesthesiologists will have it. The attending or resident anesthesiologist will give the syringe with the contents, being a blind study for the investigator and participant.
Statistical analysis will be performed using SPSS version 20.0 IBM, Microsoft Excel and numbers of iWorks for Macintosh. Statistical analysis according to the type of scaling of the variables analyzed will be performed. For comparison of dimensional variables will make a Student t test and ANOVA. For categorical variables a test of Kendall tau and chi square will be performed. Investigators will consider statistically significant any value equal or less than 0.05 or 5% for a hypothesis test two-tailed.
- Being tested
- Infiltration of 0.5% Bupivacaine, Placebo: Infiltration of 0.9% Saline Solution
- Medical subject headings
- Surgical Wound Infection, Wound Infection, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration of 0.5% BupivacaineDrug
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
Placebo: Infiltration of 0.9% Saline SolutionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo: Infiltration of 0.9% Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Purulent drainage from the incision
- Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision
- 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)
- Diagnosis of SSI by the surgeon or attending physician
Measured: 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).
Measured: Baseline to 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Salgado Nesme, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Noel Salgado-Nesme, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777866
- Sponsor's protocol ID
- CIBH-1566
- Acronym
- LAW
- Status last verified
- Apr 2016
- First submitted
- 16 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures: A Blind Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02777866
- Acronym / sponsor ID
- LAW / CIBH-1566
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an experimental, randomized, prospective, double blind study, in which will compare two groups. First group of participants 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; Second group of participants 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.
In all participants undergoing to the protocol will make basic maneuvers to decreasing surgical site infection, which has already been standardized in the Institute. These maneuvers consist of administering prophylactic antibiotic 30 minutes before the incision, shaving of the abdominal wall with clipper in the OR, preoperative skin preparation with chlorhexidine gluconate 4%. All participants will get glucose control (<200 mg / dL), maintenance of the normothermia by putting hot air in the areas not exposed to the surgery field, heating fluids and getting intraoperative hyperoxia. Blood and components will be avoided as possible.
At the moment of closing of the abdominal wall, all the surgical personal will change the surgical gloves, also all the material that will be used should be sterile. The surgical nurse will pass the solution that will be injected, the investigator will not know the contents. 1 ml of the solution will be applied for each centimeter of the wound, covering the total thickness of the wall, on each side of the wound. After the closure of the fascia, the subcutaneous tissue will be washed with 1 liter of 0.9% saline solution. The skin will be closed with metal skin staples. The total administered dose of Bupivacaine should not be greater than stated as toxic (3mg/kg).
In all participants a 0.9% saline with 200 mg of Tramadol will be indicated for 24 hours. Participants may also receive IV Tramadol bolus of 25 mg, with a maximum of 4 in a day (top dose of 300 mg/day); in those participants in whom analgesia fails to control, the investigator may use other drugs like morphine of NSAIDs. No epidural or subarachnoid analgesia will be used.
All participants will be assessed 2 times per day for the presence of pain, this will be done with a numerical verbal scale from 0 to 10, when 0 is none pain, and 10 is the greatest pain that can reaches. The investigator will review the surgical wound once daily. The participant will be assessed every 7 days once discharged from hospital, in the outpatient clinic, until 30 days after the surgical procedure.
The sample size was calculated based on the incidence of surgical site infections in the Institute, which is 5%. The sample side required to demonstrate an expected reduction of 5% to 1%, with a power of 80% and a type 1 error of 5%, is 285 participants per group.
Randomization will be done electronically, which will be assigned 285 participants in each group.The investigators will annotate the number that will be given by the program in the participant expedient. The list of the numbers will be blind for investigators, and only the attending anesthesiologists will have it. The attending or resident anesthesiologist will give the syringe with the contents, being a blind study for the investigator and participant.
Statistical analysis will be performed using SPSS version 20.0 IBM, Microsoft Excel and numbers of iWorks for Macintosh. Statistical analysis according to the type of scaling of the variables analyzed will be performed. For comparison of dimensional variables will make a Student t test and ANOVA. For categorical variables a test of Kendall tau and chi square will be performed. Investigators will consider statistically significant any value equal or less than 0.05 or 5% for a hypothesis test two-tailed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Bupivacaine 0.5% | Experimental | Drug: Infiltration of 0.5% BupivacainePatients 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 |
| 2: 0.9% Saline Solution | Placebo comparator | Drug: Placebo: Infiltration of 0.9% Saline SolutionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infiltration of 0.5% BupivacainePatients 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 | 1: Bupivacaine 0.5% |
| Placebo: Infiltration of 0.9% Saline SolutionPatients 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 | Drug | 2: 0.9% Saline Solution |
Primary outcome
Postoperative Surgical Site Infection (SSI) defined by the Centre for Disease Control (CDC) criteria
Time frame: 30 days following operation
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
Efficacy of 0.5% Bupivacaine Infiltration for Post-op Pain measured using a Numeric Scale; 0-10
Time frame: Baseline to 48 hours postoperative
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel Salgado-Nesme principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration of 0.5% Bupivacaine in people with Surgical Site Infection and Wound Infection, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noel Salgado-Nesme, MD (+52(55)54870900 ext. 2140, noelsalgadonesme@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Surgical Site Infection (SSI) defined by the Centre for Disease Control (CDC) criteria (time frame: 30 days following operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.