Elective Major Abdominal SurgeryPhase 3NCT01387568
Lidocaine Infusion for Major Abdominal Pediatric Surgery
A Phase 3 study testing Lidocaine Infusion and saline Infusion in people with Elective Major Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Elective Major Abdominal Surgery
- What is being tested?
- Lidocaine Infusion and saline Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2010to Feb 2011
- Phase
- Phase 3
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric
- Abdominal surgery
- ASA class I and II
Who cannot join
- history of hepatic diseases
- history of cardiac diseases
- history of renal diseases
- allergy to local anesthetics
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study
In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.
Read the detailed description
The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.
Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.
- Conditions
- Elective Major Abdominal Surgery
- Being tested
- Lidocaine Infusion, saline Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine InfusionDrug
children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively
saline InfusionDrug
children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| group L | Active comparator | Lidocaine group Receives: Drug: Lidocaine Infusion |
| group P | Placebo comparator | Placebo group Receives: Drug: saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: for 2hrs after infusion
Secondary outcomes (4)
Plasma Cortisol
Measured: for 24 hrs after infusion
Serum lidocaine
The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine
Measured: 6 hrs after infusion
Heart rate (HR)
Measured: for 6 hrs after infusion
Pain scales
In the postanaesthetic care unit (PACU), children were assessed for pain every 10 min by the trained nurse blinded to group assignment, using 1 of 2 pain scales according to child comprehension: a 0- to 10-point visual analog scale (VAS), or FLACC Scale (Face, Legs,Activity, Cry, Consolability). FLACC is an observer assessment based 5 items and each item is graded from 0 to 2
Measured: 24 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
- Investigators
- Alaa El Deep, MD, Principal investigator, alaaeldeep9@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387568
- Sponsor's protocol ID
- MUH-AD-1-2011
- Status last verified
- Apr 2012
- First submitted
- 29 Jun 2011
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study
- ClinicalTrials.gov ID
- NCT01387568
- Acronym / sponsor ID
- MUH-AD-1-2011
- Conditions
- Elective Major Abdominal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Jul 2011 (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.
In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.
Detailed description
The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.
Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group L | Active comparator | Drug: Lidocaine InfusionLidocaine group |
| group P | Placebo comparator | Drug: saline InfusionPlacebo group |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric
- Abdominal surgery
- ASA class I and II
Key exclusion criteria (5 listed)
- history of hepatic diseases
- history of cardiac diseases
- history of renal diseases
- allergy to local anesthetics
- epilepsy
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 |
|---|---|---|
| Lidocaine Infusionchildren in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively | Drug | group L |
| saline Infusionchildren in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively | Drug | group P |
Primary outcome
Blood pressure
Time frame: for 2hrs after infusion
4 secondary outcomes
Plasma Cortisol
Time frame: for 24 hrs after infusion
Serum lidocaine
Time frame: 6 hrs after infusion
Heart rate (HR)
Time frame: for 6 hrs after infusion
Pain scales
Time frame: 24 hrs postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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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.
Alaa El Deep, MD principal investigator
alaaeldeep9@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Infusion and saline Infusion in people with Elective Major Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Apr 2012. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: for 2hrs after infusion). 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 20 Apr 2012.