Skip to main content
OpenTrials
Completed

NCT Number: NCT03748108

Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

The objective of the study to evaluate whether a bolus administration of intravenous lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after abdominal hysterectomy compared with placebo.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Hysterectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide. Some studies noticed about abused of opioids in postoperative care, led to a more adverse effect of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase the unnecessary cost of treatment.

Guidelines have considered using preoperative analgesics for reducing post-operative opioids consumption, including lidocaine infusion. With its anti-inflammatory, anti-hyperalgesia and analgesic properties, intravenous perioperative lidocaine infusion (IVLI) has been used for optimal postoperative care in different surgeries and in various procedures involving hysterectomy.

Therefore, the aim of this study is to assess the efficacy of bolus administration of intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain and reducing morphine requirements, after TAH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ranging age between 35-60 years a who undergoing elective total abdominal hysterectomy

Exclusion criteria

  • Participants had known sensitivity to lidocaine
  • Participants had difficulty in intubation
  • Participants were on chronic pain medication or already on long-term opioids
  • Participants smokers
  • Participants with disabilities who were unable to communicate pain levels
  • refuse to consent

Treatment and study plan

Lidocaine

Drug

a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.

Other names: Experimental

Placebo

Drug

a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.

Other names: Placebo Comparator

Primary outcomes

  1. Visual analog score during movement

    Time frame: 30 minutes postoperative

    movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary outcomes

  1. Visual analog score during rest

    Time frame: 24 hours post operative

    ranging from 0 to 10, where 0 no pain and 10

  2. number of patients need Fentanyl consumption

    Time frame: 24 hours post operative

    number of patients need Fentanyl consumption

  3. number of days patients stay in hospital

    Time frame: 4 weeks

    calculation of number of days patients stay in hospital

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

A Randomized Clinical Trial Estimating the Efficacy of Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy to Decrease Postoperative Pain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.