Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

Study 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.

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

Conditions
-----------------
Abdominal Hysterectomy

Intervention / Treatment
-----------------
* Drug: lidocaine
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine<br>A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia. | Drug: lidocaine<br>* a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.<br>* Other names: Experimental;|
| Placebo Comparator: Placebo<br>A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia. | Drug: Placebo<br>* a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.<br>* Other names: Placebo Comparator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score during movement | movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain | 30 minutes postoperative | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lidocaine, Postoperative Pain, hysterectomy