Colorectal SurgeryPhase 1NCT02241096
PK Intravenous Lidocaine Infusion
A Phase 1 study testing Lidocaine in people with Colorectal Surgery, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
To determine safe concentration level of lidocaine infusion in children. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 1
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female children 3-15 years of age
- ASA physical status 1-3
- scheduled for colorectal surgery with abdominal incision
Who cannot join
- ASA physical status > 3
- postoperative intubation planned ahead of surgery
- history of chronic use of opioid (use longer than 3 months)
- history of hepatic, renal, or cardiac failure
- history of significant liver disease including liver failure, acute or chronic hepatitis, hepatomegaly, portal hypertension and elevated liver enzymes
- history of organ transplant
Show all 13Show fewer
- BMI > 30
- history of cardiac arrhythmia
- history of long QT syndrome
- history of allergic reaction to lidocaine or similar agents
- history of seizure disorder
- patient without PICC or other central access with contraindication to inhalation induction
- family history or known patient susceptibility to malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Pharmacokinetics of Intravenous Lidocaine Infusion in Children
To determine safe concentration level of lidocaine infusion in children.
Read the detailed description
This study will address the working hypothesis that intravenous lidocaine may be administered as a bolus followed by an infusion with reliable and safe blood levels of lidocaine. Serial blood draws will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.
- Conditions
- Colorectal Surgery
- Being tested
- Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called xylocaine
IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
Blood samples will be obtained at predetermined times after start and finish of lidocaine infusion. Each sample is 1ml. Samples will be obtained at the baseline placement of IV, 0 - 3 minutes after bolus has completed, 9 - 15 minutes after bolus infusion, 4 minutes prior to end or at the end of the continuous infusion, 55 - 65 following the end of infusion, 2 - 7 hours after completion of continuous infusion and 20 - 24 hours after completion of infusion if clinical labs are also necessary.
Measured: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Secondary outcomes (1)
Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions
We will monitor monoethylglycinexylidide (MEGX) and glycinexylidide (GX).
Blood samples (1ml each) for metabolites will be as follows: baseline with initial placement, 4 minutes after infusion completed, 2 - 7 hours after infusion completion, 20 - 24 hours after infusion completion if clinical labs are being drawn
Measured: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Lack of available study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smokey J Clay, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241096
- Sponsor's protocol ID
- 2014-3194
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2014
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PubMed 17197840Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PubMed 9459225Candiotti KA, Yang Z, Morris R, Yang J, Crescimone NA, Sanchez GC, Bird V, Leveillee R, Rodriguez Y, Liu H, Zhang YD, Bethea JR, Gitlin MC. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology. 2011 May;114(5):1162-8. doi: 10.1097/ALN.0b013e318216e9cb.
PubMed 21455057Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
PubMed 19843784Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
PubMed 16952918Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.
PubMed 19285304Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. doi: 10.1542/peds.110.3.e33.
PubMed 12205283McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.
PubMed 8783307
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intravenous Lidocaine Infusion in Children
- ClinicalTrials.gov ID
- NCT02241096
- Acronym / sponsor ID
- 2014-3194
- Conditions
- Colorectal Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of available study participants.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Sep 2014 (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.
To determine safe concentration level of lidocaine infusion in children.
Detailed description
This study will address the working hypothesis that intravenous lidocaine may be administered as a bolus followed by an infusion with reliable and safe blood levels of lidocaine. Serial blood draws will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineIV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- male or female children 3-15 years of age
- ASA physical status 1-3
- scheduled for colorectal surgery with abdominal incision
Key exclusion criteria (13 listed)
- ASA physical status > 3
- postoperative intubation planned ahead of surgery
- history of chronic use of opioid (use longer than 3 months)
- history of hepatic, renal, or cardiac failure
- history of significant liver disease including liver failure, acute or chronic hepatitis, hepatomegaly, portal hypertension and elevated liver enzymes
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 |
|---|---|---|
| LidocaineAlso: xylocaineIV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion. | Drug | Lidocaine |
Primary outcome
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
Time frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Blood samples will be obtained at predetermined times after start and finish of lidocaine infusion. Each sample is 1ml. Samples will be obtained at the baseline placement of IV, 0 - 3 minutes after bolus has completed, 9 - 15 minutes after bolus infusion, 4 minutes prior to end or at the end of the continuous infusion, 55 - 65 following the end of infusion, 2 - 7 hours after completion of continuous infusion and 20 - 24 hours after completion of infusion if clinical labs are also necessary.
1 secondary outcome
Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions
Time frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Results and safety
The study was stopped early (reason given: Lack of available study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 17197840Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Background: PubMed 9459225Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Background: PubMed 21455057Candiotti KA, Yang Z, Morris R, Yang J, Crescimone NA, Sanchez GC, Bird V, Leveillee R, Rodriguez Y, Liu H, Zhang YD, Bethea JR, Gitlin MC. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology. 2011 May;114(5):1162-8. doi: 10.1097/ALN.0b013e318216e9cb.
- Background: PubMed 19843784Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
- Background: PubMed 16952918Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
- Background: PubMed 19285304Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.
- Background: PubMed 12205283Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. doi: 10.1542/peds.110.3.e33.
- Background: PubMed 8783307McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.
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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.
Smokey J Clay, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine in people with Colorectal Surgery, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 13 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: stopped early, as of the sponsor's last update on 2 Mar 2020. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Lack of available study participants.). Results are not available in the source record.
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?
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood) (time frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241096, which also lists 8 linked publications.
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 2 Mar 2020.