Perioperative Protective Effects of Lidocaine

NCT00413127 | Terminated Phase 2

• 1 other identifier: 06-AnIt-06
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery

Conditions

Elective Surgical Procedure; Colorectal Surgery

Keywords

Systemic lidocaine; peridural lidocaine; perioperative analgesia; inflammation; Anesthesia

Outcome Measures

Primary Outcomes (1)

• length of postoperative hospital stay

  end of hospital stay

Secondary Outcomes (7)

• Hyperalgesia perioperative

  postoperative day 2, 4, 8, end of hospital stay and follow-up

• Cytokine levels perioperative

  before surgery and 4 hours, 2 and 4 days after surgery

• Bowel motility perioperative

  days after surgery

• Length of PACU stay

  end of PACU stay

• Cognitive function perioperatively

  before surgery, one and four days after surgery, at end of hospital stay and follow-up

Study Arms (5)

1

EXPERIMENTAL

Lidocaine i.v

Drug: lidocaine

2

ACTIVE COMPARATOR

intraoperatively lidocaine epidural postoperatively lidocaine i.v.

Drug: lidocaine

3

ACTIVE COMPARATOR

intraoperatively lidocaine i.v. postoperatively lidocaine epidural

Drug: lidocaine

4

ACTIVE COMPARATOR

lidocaine epidural

Drug: lidocaine

5

PLACEBO COMPARATOR

placebo i.v.

Drug: NaCl 0,9%

Interventions

lidocaine DRUG

administration of lidocaine intravenously or epidural or administration of placebo

1; 2; 3; 4

NaCl 0,9% DRUG

Administration of placebo i.v.

5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective colorectal surgery

You may not qualify if:

• ASA \> 3
• history of anti-inflammatory therapy
• history of inflammatory bowl diseases
• history of chronic pain treatment

Sponsors & Collaborators

• University Hospital Muenster: lead
• International Anesthesia Research Society (IARS): collaborator

Study Sites (3)

University Hospital Muenster

Münster, D-48129, Germany

Location

St. Franziskushospital Muenster

Münster, D-48145, Germany

Location

St. Marienhospital

Vechta, D-49377, Germany

Location

Related Publications (2)

• 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

• Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. doi: 10.1016/s0140-6736(77)90727-9.

  PMID: 71604 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• K Hahnenkamp, MD

  Department of Anesthesiology and Intensive Care, University Hospital Muenster

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: September 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

DE (3)