Intravenous Lidocaine and Postoperative Pain Management

Postoperative Pain Management Clinical Trial

Official title:

Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02997215
• Other study ID #: 2015-YJJ-GGL-008
• Status: Recruiting
• Phase: Phase 4
• First received: December 6, 2016
• Last updated: December 16, 2016
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Chinese Medical Association
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management

Intervention

Drug:
• Lidocaine
lidocaine infusion during surgery
• Saline Placebo
saline infusion at same rate as intervention group during surgery

Locations

Country	Name	City	State
China	Department of Anesthesiology; Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	visual analogue score (1-10)	6 hours after surgery	Yes
Primary	postoperative pain score	visual analogue score (1-10)	24 hours after surgery	Yes
Primary	postoperative pain score	visual analogue score (1-10)	72 hours after surgery	Yes
Primary	total postoperative opioid consumption	postoperative fentanyl consumption	48 hours after surgery	Yes
Secondary	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	Yes