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

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05541640

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery	Drug: normal saline group Drug: lidocaine group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group	Drug: normal saline group normal saline infusion at the start of surgery
Active Comparator: lidocaine group	Drug: lidocaine group lidocaine infusion at the start of surgery

Arm

Intervention/Treatment

Placebo Comparator: control group

Drug: normal saline group

normal saline infusion at the start of surgery

Active Comparator: lidocaine group

Drug: lidocaine group

lidocaine infusion at the start of surgery

Outcome Measures

Primary Outcome Measures

postoperative visual analogue score (VAS SCORE) [24 hour]
assessment of postoperative pain will be carried by VAS in which zero=no pain and 10= worst pain ever

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rasha Hamed, asisstant lecturer of anaesthesia and pain management, Assiut University

ClinicalTrials.gov Identifier:

NCT05541640

Other Study ID Numbers:

zzzz

First Posted:

Sep 15, 2022

Last Update Posted:

Sep 15, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Sep 15, 2022