Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy
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|ClinicalTrials.gov Identifier: NCT03748108|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Hysterectomy||Drug: lidocaine Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.|
|Official Title:||A Randomized Clinical Trial Estimating the Efficacy of Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy to Decrease Postoperative Pain|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||May 1, 2020|
A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
Other Name: Experimental
Placebo Comparator: Placebo
A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.
a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.
Other Name: Placebo Comparator
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748108
|Contact: hany f sallam||01022336052 ext email@example.com|
|Principal Investigator:||hany f sallam, md||Aswan University Hospital|