Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

Overview

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.

Full Title of Study: “A Randomized Clinical Trial Estimating the Efficacy of Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy to Decrease Postoperative Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2020

Detailed Description

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.

Interventions

  • Drug: lidocaine
    • a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
  • Drug: Placebo
    • a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.

Arms, Groups and Cohorts

  • Experimental: lidocaine
    • A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
  • Placebo Comparator: Placebo
    • A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Visual analog score during rest
    • Time Frame: 24 hours post operative
    • ranging from 0 to 10, where 0 no pain and 10
  • number of patients need Fentanyl consumption
    • Time Frame: 24 hours post operative
    • number of patients need Fentanyl consumption
  • number of days patients stay in hospital
    • Time Frame: 4 weeks
    • calculation of number of days patients stay in hospital

Participating in This Clinical Trial

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

Gender Eligibility: Female

women undergoing abdominal hysterectomy

Minimum Age: 35 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aswan University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: hany farouk, Principal Investigator – Aswan University Hospital
  • Overall Official(s)
    • hany f sallam, md, Principal Investigator, Aswan University Hospital

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