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TerminatedNCT00413127Updated Jun 26, 2015

Perioperative Protective Effects of Lidocaine

A Phase 2/3 interventional study of lidocaine and NaCl 0,9% in Elective Surgical Procedure and Colorectal Surgery, sponsored by University Hospital Muenster. Terminated at 3 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-06-26.

Sponsored by University Hospital Muenster · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Less patients than expected for inclusion, therefore patient recruitment is to low
Phase
Phase 2/3
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Elective Surgical Procedure
  • Colorectal Surgery

Keywords

  • Systemic lidocaine
  • peridural lidocaine
  • perioperative analgesia
  • inflammation
  • Anesthesia
03

In context

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective colorectal surgery

Exclusion criteria

Exclusion Criteria:

  • ASA > 3
  • history of anti-inflammatory therapy
  • history of inflammatory bowl diseases
  • history of chronic pain treatment
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    1

    Lidocaine i.v

    Drug: lidocaine

  • Active comparator
    2

    intraoperatively lidocaine epidural postoperatively lidocaine i.v.

    Drug: lidocaine

  • Active comparator
    3

    intraoperatively lidocaine i.v. postoperatively lidocaine epidural

    Drug: lidocaine

  • Active comparator
    4

    lidocaine epidural

    Drug: lidocaine

  • Placebo comparator
    5

    placebo i.v.

    Drug: NaCl 0,9%

Interventions

  • Druglidocaine

    administration of lidocaine intravenously or epidural or administration of placebo

  • DrugNaCl 0,9%

    Administration of placebo i.v.

06

What researchers measure

Primary outcomes

  1. length of postoperative hospital stay

    Time frame: end of hospital stay

Secondary outcomes

  1. Hyperalgesia perioperative

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

  2. Cytokine levels perioperative

    Time frame: before surgery and 4 hours, 2 and 4 days after surgery

  3. Bowel motility perioperative

    Time frame: days after surgery

  4. Length of PACU stay

    Time frame: end of PACU stay

  5. Cognitive function perioperatively

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

  6. Incidence of wound healing disturbances

    Time frame: within 4 weeks after surgery

  7. Postoperative Analgesia

    Time frame: until end of hospital stay

07

Study locations

3 sites
  • University Hospital Muenster
    Muenster, D-48129, Germany
  • St. Franziskushospital Muenster
    Muenster, D-48145, Germany
  • St. Marienhospital
    Vechta, D-49377, Germany
08

References and documents

Publications

  • 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. PubMed 16952918 ↗
  • 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. PubMed 71604 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00413127
Lead sponsor
University Hospital Muenster
Collaborators
International Anesthesia Research Society (IARS)
Responsible party
Sponsor
First posted
Dec 19, 2006
Start date
Sep 2007
Primary completion
Mar 2014
Completion
Mar 2015
Last update
Jun 26, 2015

Study contacts

K Hahnenkamp, MD
study chair · Department of Anesthesiology and Intensive Care, University Hospital Muenster

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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