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Clinical Trials/NCT03748108
NCT03748108
Completed
Not Applicable

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

Aswan University Hospital1 site in 1 country120 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
lidocaine
Conditions
Abdominal Hysterectomy
Sponsor
Aswan University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Visual analog score during movement
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Aswan University Hospital
Responsible Party
Principal Investigator
Principal Investigator

hany farouk

Principal Investigator

Aswan University Hospital

Eligibility Criteria

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

Arms & Interventions

lidocaine

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

Intervention: lidocaine

Placebo

A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.

Intervention: Placebo

Outcomes

Primary Outcomes

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

  • Visual analog score during rest(24 hours post operative)
  • number of patients need Fentanyl consumption(24 hours post operative)
  • number of days patients stay in hospital(4 weeks)

Study Sites (1)

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