Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery

Enhanced Recovery After Surgery Clinical Trial

Official title:

Effect of Intraoperative Lidocaine Infusion on Inducing Intestinal Motility and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery. A Prospective, Comparative, Randomized Double Blind Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541640
• Other study ID #: zzzz
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lidocaine is an amide local anaesthetic and an antiarrhythmic agent, first synthesized in 1942, and after approval for human use was launched in 1948 in Sweden The first observations of post operative analgesic effects of perioperative intravenous lidocaine (IVL) were initially proposed in 1951 subsequently many more enthusiastic reports followed. Postoperative formal clinical evaluations in the perioperative setting were conducted in the late 1950s where IV Lidocaine was demonstrated to have a postoperative analgesic effect without posing the risk of respiratory depression, reducing the occurrence of postoperative nausea and vomiting (PONV), and enhance post-surgical recovery. IV Lidocaine also potentiated the depth of anesthesia and led to a better tolerance of endotracheal intubation.Around 40% of patients experience a delay in resumption of normal bowel function after colorectal surgery. This delay leads to symptoms of nausea, vomiting, constipation, and abdominal distension, which then require unpleasant supportive interventions such as intravenous fluids and nasogastric tube insertion. There is no remedy to address this delay. ALLEGRO, "A placebo-controlled randomized trial of intravenous Lidocainein accelerating Gastrointestinal Recovery surgery," is the latest ongoing multicenter research study across the United Kingdom, investigating the use of intravenous lidocaine to improve recovery after colorectal surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18 years and older.
• Both sexes, males and females
• Patients scheduled for elective intestinal surgery.
• Body mass index (BMI) 18-30 kg•m-2.
• ASA I - II.

Exclusion Criteria:

• Patient refusal
• Patients with preoperative gastrointestinal dysfunction.
• Patients with a history of drug abuse, or long-term opioid use.
• ASA III and VI
• Patients with a history of previous gastrointestinal surgery

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

Drug:
• normal saline group
normal saline infusion at the start of surgery
• lidocaine group
lidocaine infusion at the start of surgery

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative visual analogue score (VAS SCORE)	assessment of postoperative pain will be carried by VAS in which zero=no pain and 10= worst pain ever	24 hour