Intravenous Lidocaine and Postoperative Pain Management

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain Management

Treatments: Drug: Saline Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02997215

2015-YJJ-GGL-008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy.

Exclusion criteria

• Open surgery;
• Patients allergic to lidocaine or other local anesthetics;
• Drug abuser.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

intravenous lidocaine

Experimental group

Description:

intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.

Treatment:

Drug: Lidocaine

saline placebo

Placebo Comparator group

Description:

same amount volume saline infusion

Treatment:

Drug: Saline Placebo