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

NCT05541640 | Unknown DMC

• 1 other identifier: zzzz
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

PLACEBO COMPARATOR

Drug: normal saline group

lidocaine group

ACTIVE COMPARATOR

Drug: lidocaine group

Interventions

normal saline group DRUG

normal saline infusion at the start of surgery

control group

lidocaine group DRUG

lidocaine infusion at the start of surgery

lidocaine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asisstant lecturer of anaesthesia and pain management

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 30, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

EG (1)