NCT00789620

Brief Summary

Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects from pain relieving medication minimized with a potential for a more rapid postoperative recovery and less complications. IV application of lidocaine should de-crease the duration of bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay (primary outcome). We expect that the intraoperative inflammatory response can significantly be reduced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Nov 2008

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

2.3 years

First QC Date

November 11, 2008

Last Update Submit

March 23, 2011

Conditions

PainFatigue

Keywords

intravenous lidocainelaparoscopic urological surgeryhospital staypainfatiguelength of stay

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    end of hospitalisation

Secondary Outcomes (5)

  • change in pain score

    2 and 4 h postop and 3*/d on day 1 and 2

  • changes in fatigue score

    2 and 4 h postop and 3*/d on day 1 and 2

  • PONV

    2 and 4 h postop and 3*/d on day 1 and 2

  • time to first episode of flatus and defecation

    2 and 4 h postop and 3*/d on day 1 and 2

  • changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)

    preoperatively and on day 1 and 2 in the morning

Study Arms (2)

1

ACTIVE COMPARATOR

Lidocaine 1% administrated as a bolus of 1.5 mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24 h

Drug: lidocaine

2

PLACEBO COMPARATOR

NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h

Drug: placebo

Interventions

lidocaineDRUG

1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h

1
placeboDRUG

Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • ASA 1 to 3
  • Laparoscopic transperitoneal urological surgery

You may not qualify if:

  • Liver insufficiency
  • Steroid therapy
  • Chronic opioid therapy
  • Allergy to lidocaine
  • Pre-existing disorder of the gastrointestinal tract
  • AV-block II-III, sinusbradycardia, heart insufficiency, long QT-syndrome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Urology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Wuethrich PY, Romero J, Burkhard FC, Curatolo M. No benefit from perioperative intravenous lidocaine in laparoscopic renal surgery: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2012 Nov;29(11):537-43. doi: 10.1097/EJA.0b013e328356bad6.

    PMID: 22907609DERIVED

MeSH Terms

Conditions

PainFatigue

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Patrick Y Wüthrich, MD

    Dep. of Anesthesiology and pain service, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

CH(1)