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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine | Experimental | A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia. |
|
| Placebo | Placebo Comparator | A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | Drug | a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
women undergoing abdominal hysterectomy
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| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.
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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.
| Placebo | Drug | a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia. |
|
|
| 24 hours post operative |
| number of days patients stay in hospital | calculation of number of days patients stay in hospital | 4 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |