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

NCT01836614 | Withdrawn Phase 1 DMC

• 1 other identifier: CCHMC 2012-0674
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Postoperative pain scores

  participants will be followed post-op, average 5 days

• Cumulative morphine consumption

  participants will be followed post-op, average 5 days

• Incidences of opioid adverse-effects

  participants will be followed post-op, average 5 days

• Time to passage of flatus and bowel movement

  participants will be followed post-op, average 5 days

• End-tidal Sevoflurane in operating room throughout surgery

  participants will be measured until the end of the OR case, on average 6 hours

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes. The 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 operating room or after 5 hours from the start of the infusion

Drug: Lidocaine

Saline

PLACEBO COMPARATOR

The saline will be administered over an infusion pump over 10 minutes and followed by a bolus. The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion.

Drug: Lidocaine

Interventions

Lidocaine DRUG

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.

Lidocaine; Saline

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (13)

• 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.

  PMID: 17197840 BACKGROUND

• 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. doi: 10.1097/00000539-199802000-00003.

  PMID: 9459225 BACKGROUND

• 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.

  PMID: 21455057 BACKGROUND

• 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.

  PMID: 19843784 BACKGROUND

• 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. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.

  PMID: 16952918 BACKGROUND

• 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.

  PMID: 19285304 BACKGROUND

• Bulloch 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.

  PMID: 12205283 BACKGROUND

• 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):435-443. doi: 10.1016/0304-3959(95)00171-9.

  PMID: 8783307 BACKGROUND

• Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. doi: 10.1111/j.1460-9592.2007.02213.x.

  PMID: 17596221 BACKGROUND

• 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. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

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

  PMID: 19224799 BACKGROUND

• 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):265-273. doi: 10.1097/01.md.0000141096.00377.3f.

  PMID: 15342970 BACKGROUND

• LUND PC, CWIK JC. PROPITOCAINE (CITANEST) AND METHEMOGLOBINEMIA. Anesthesiology. 1965 Jul-Aug;26:569-71. doi: 10.1097/00000542-196507000-00020. No abstract available.

  PMID: 14313465 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Smokey J Clay, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 22, 2013
• Study Start: January 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)