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Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

Not Applicable
Completed
Conditions
Abdominal Hysterectomy
Interventions
Drug: Placebo
Registration Number
NCT03748108
Lead Sponsor
Aswan University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboA bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.
lidocainelidocaineA bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
Primary Outcome Measures
NameTimeMethod
Visual analog score during movement30 minutes postoperative

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

Secondary Outcome Measures
NameTimeMethod
Visual analog score during rest24 hours post operative

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

number of patients need Fentanyl consumption24 hours post operative

number of patients need Fentanyl consumption

number of days patients stay in hospital4 weeks

calculation of number of days patients stay in hospital

Trial Locations

Locations (1)

Aswan University

🇪🇬

Aswan, Egypt

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