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Endovenous Lidocaine and Serum Cytokines Concentration

U

Universidade Federal de Santa Maria

Status and phase

Completed
Phase 4

Conditions

Cholelithiasis

Treatments

Drug: Saline solution
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02363699
LIDOCAINE X CYTOCINES

Details and patient eligibility

About

Ineffective treatment of postoperative pain may cause organic damage and chronic pain. Nevertheless, opioids, the leading drugs used for this purpose, present side effects that sometimes restrict their usability. In a multimodal context, new postoperative analgesia techniques have been developed focusing in the reduction of opioid use and their adverse effects, as well as postoperative chronic pain prevention. In this background, continuous intravenous infusion of lidocaine during perioperative period has shown to be promising. This trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a control group. Intravenous lidocaine in the perioperative period of laparoscopic cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by the significant changes in the studied cytokines.

Full description

Forty-four patients undergoing laparoscopic cholecystectomy, under general anesthesia, were randomly allocated in two groups. The first group received intravenous lidocaine infusion during the procedure until one hour postoperatively; meanwhile the second group received intravenous saline for the same period of time. The intervention was double-blind. In the postoperative period, both groups received dipyrone and morphine PCA. Pain was assessed by Visual Numeric Scale (VNS) at rest and when coughing at 1st, 2nd, 4th, 12th e 24th hour after the end of the surgery. Blood samples for cytokines measurement were taken at the end of procedure and 24 hours later. The total morphine PCA demand, the time for the first flatus and the length of hospital stay were also recorded and compared.

Enrollment

44 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age over 18 years and
  • physical status according to the American Society of Anesthesiologists (ASA) I and II

Exclusion criteria

  • patients older than 75 years,

  • patients with heart disease,

  • patients with history of:

    • kidney failure,
    • liver failure,
    • psychiatric disorder,
    • chronic use of opioids or medications that could cause induction of liver enzymes (anticonvulsants).
  • the presentation of adverse effects during the intervention or postoperative complications, and the conversion to open surgery.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

44 participants in 2 patient groups, including a placebo group

Lidocaine
Active Comparator group
Description:
Group treated with lidocaine solution
Treatment:
Drug: Lidocaine
Placebo
Placebo Comparator group
Description:
Group treated with saline solution
Treatment:
Drug: Saline solution

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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