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This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.
Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects.
Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous lidocaine | Experimental | intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure. |
|
| saline placebo | Placebo Comparator | same amount volume saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | lidocaine infusion during surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain score | visual analogue score (1-10) | 6 hours after surgery |
| postoperative pain score | visual analogue score (1-10) | 24 hours after surgery |
| postoperative pain score | visual analogue score (1-10) | 72 hours after surgery |
| total postoperative opioid consumption | postoperative fentanyl consumption | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative complication | opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine. | 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology; Beijing Tongren Hospital | Recruiting | Beijing | 100730 | China |
De-identified individual participants data for primary and secondary outcome measures will be available within 6 months of study completion
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline Placebo |
| Drug |
saline infusion at same rate as intervention group during surgery |
|
| Aniline Compounds |
| D000588 | Amines |