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Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

A

Aswan University Hospital

Status

Completed

Conditions

Abdominal Hysterectomy

Treatments

Drug: Placebo
Drug: lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03748108
aswu/275/18

Details and patient eligibility

About

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 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.

Enrollment

120 patients

Sex

Female

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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