Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients

Colorectal Disorders Clinical Trial

Official title:

Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01836614
• Other study ID #: CCHMC 2012-0674
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 8, 2013
• Last updated: March 7, 2016
• Start date: January 2015
• Est. completion date: April 2018

Study information

• Verified date: March 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if an intravenous lidocaine infusion (compared to placebo) intraoperatively will decrease time to return of bowel function postoperatively, decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory markers and shorten time to discharge after colorectal surgery.

Description:

Lidocaine is an amide local anesthetic that has analgesic and anti-inflammatory properties. Lidocaine infusion is a very useful pain medication that is underutilized to treat surgical, chronic, and cancer pain in children. The investigators propose to examine the perioperative use of lidocaine infusion in children undergoing colorectal surgery that involves an abdominal incision. The investigators plan to measure the following outcomes: length of stay in hospital following abdominal surgery, postoperative pain scores, cumulative morphine consumption, incidences of opioid adverse-effects: respiratory depression, sedation, nausea, vomiting, time to passage of flatus, time to first bowel movement and end-tidal Sevoflurane in operating room throughout surgery. The following laboratory values will be measured: serial lidocaine levels of pharmacokinetics and safety levels, Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA and genetic variants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• male or female children 1-15 years of age

• ASA physical status 1-3

• scheduled for colorectal surgery with abdominal incision

• scheduled for complex urology surgical case

Exclusion Criteria:

• ASA physical status > 3

• postoperative intubation planned ahead of surgery

• history of chronic use of opioid

• history of hepatic,renal, or cardiac failure

• history of organ transplant

• 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 Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction

• family history or know patient susceptibility to malignant hyperthermia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Disorders
• Pain, Postoperative

Intervention

Drug:
• Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump. This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr. The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (13)

Annabi EH, Barker SJ. Severe methemoglobinemia detected by pulse oximetry. Anesth Analg. 2009 Mar;108(3):898-9. doi: 10.1213/ane.0b013e318172af73. — View Citation

Ash-Bernal R, Wise R, Wright SM. Acquired methemoglobinemia: a retrospective series of 138 cases at 2 teaching hospitals. Medicine (Baltimore). 2004 Sep;83(5):265-73. — View Citation

Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. — View Citation

Candiotti 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. — View Citation

Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. Review. — View Citation

Groudine 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. — View Citation

Harvey 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. Review. — View Citation

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. — View Citation

Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. — View Citation

Kuo 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. Epub 2006 Sep 4. — View Citation

LUND PC, CWIK JC. PROPITOCAINE (CITANEST) AND METHEMOGLOBINEMIA. Anesthesiology. 1965 Jul-Aug;26:569-71. — View Citation

McGrath 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):435-43. — View Citation

Yardeni 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in hospital following abdominal surgery	The primary outcome measure will be to monitor the length of stay in hospital following abdominal surgery.	participants will be followed for the duration of hospital stay, an average of 1 week	No
Secondary	Postoperative pain scores	Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.	participants will be followed post-op, average 5 days	No
Secondary	Cumulative morphine consumption	Staff will document how much morphine a patient uses post-operatively after abdominal surgery.	participants will be followed post-op, average 5 days	No
Secondary	Incidences of opioid adverse-effects	Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting	participants will be followed post-op, average 5 days	No
Secondary	Time to passage of flatus and bowel movement	Study staff will review nursing notes for time of passage of flatus and first bowel movement.	participants will be followed post-op, average 5 days	No
Secondary	End-tidal Sevoflurane in operating room throughout surgery		participants will be measured until the end of the OR case, on average 6 hours	No
Secondary	Serial lidocaine levels for pharmacokinetics and safety levels	2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs	participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively	No
Secondary	Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA	2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs	participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively	No
Secondary	Genetic variants	2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs	participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively	No