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

NCT ID: NCT05541640

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-30

Brief 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

Conditions

Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

Group Type: PLACEBO_COMPARATOR

normal saline group

Intervention Type: DRUG

normal saline infusion at the start of surgery

lidocaine group

Group Type: ACTIVE_COMPARATOR

lidocaine group

Intervention Type: DRUG

lidocaine infusion at the start of surgery

Interventions

normal saline group

normal saline infusion at the start of surgery

Intervention Type: DRUG

lidocaine group

lidocaine infusion at the start of surgery

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rasha Hamed

asisstant lecturer of anaesthesia and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

rasha hamed, MD

Role: primary

rashaahmed11@yahoo.nom

0882413201

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id