Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy (O-S Anesthesia)

Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy: a Randomized Controlled Trial

Aim of the Work The investigators aim to compare lidocaine-based anesthesia versus conventional anesthesia in the presence of multimodal analgesia protocol in terms of early quality of recovery and analgesic efficacy.

Objectives To compare quality of recovery using the Quality of recovery-15 (QoR-15) score between lidocaine-based anesthesia in relation to conventional anesthesia in patients undergoing emergency laparotomy.

Hypothesis the investigators hypothesize that lidocaine-based regimen would be effective in reducing opioid use and provide superior quality of recovery compared to conventional opioid-routine anesthesia in emergency laparotomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia Recovery Period
• Intervention / Treatment: Drug: : two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as conti; Drug: A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai Madkour, Associate professor; Phone Number: +201223657694; Email: maimadkour@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18-65 years)
• ASA I-III undergoing emergency laparotomy with midline incision.

Exclusion Criteria:

• Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions) and patients on beta-blockers
• Patients on vasopressor infusion, patients with high shock index (heart rate / systolic blood pressure >1)

• Body mass index <18 or > 35 Kg/m2,

  • Pregnant or lactating women,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: opioid sparing; two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as continuous infusion.	Drug: : two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as conti; : two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as continuous infusion.
Placebo Comparator: conventional; A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.	Drug: A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.; A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Quality of recovery using the QoR-15 score 24 h after surgery.	- Quality of recovery using the QoR-15 score 24 h after surgery. An 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed; maximum score 150).	24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 12, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Lidocaine; Fentanyl
• Other Study ID Numbers: ty7890567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No