Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01439399

Enrollment

Registered

2011-09-23

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption

Brief summary

The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

Detailed description

Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Interventions

DRUGLidocaine,

Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.

DRUGKetamine

Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.

DRUGassociation ketamine-lidocaine

Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.

DRUGPlacebo

The control group (C) received an equal volume of saline 0.9 % during 48 h.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* abdominal surgery by laparotomy

Exclusion criteria

* laparoscopy * history of chronic pain * opioid self-administration * psychiatric disorders * difficulties with communication * renal or hepatic dysfunction * ASA physical status \> 3

Design outcomes

Primary

Measure	Time frame	Description
Cumulative morphine consumption	48 hours	Cumulative morphine consumption over 48 hours postoperatively

Secondary

Measure	Time frame	Description
Pain scores	48 hours	Pain scores at rest and movement
Mechanical hyperalgesia	48 hours	Mechanical hyperalgesia using pressure algometry
Occurrence of side effects	48 hours	Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026