Abdominal Hysterectomy
Conditions
Keywords
lidocaine, Postoperative Pain, hysterectomy
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.
Interventions
DRUGlidocaine
a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
DRUGPlacebo
a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog score during movement | 30 minutes postoperative | movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients need Fentanyl consumption | 24 hours post operative | number of patients need Fentanyl consumption |
| number of days patients stay in hospital | 4 weeks | calculation of number of days patients stay in hospital |
| Visual analog score during rest | 24 hours post operative | ranging from 0 to 10, where 0 no pain and 10 |
Countries
Egypt
Outcome results
None listed