Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy

NCT07262242 | Not Yet Recruiting

• 1 other identifier: MD-5-2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Opioids are widely used during anesthesia for pain control, but they cause many side effects-such as nausea, constipation, respiratory depression, dependence, and delayed recovery. They can also worsen low blood pressure in patients with unstable circulation. Because of these risks, multimodal analgesia is recommended to reduce opioid use. Research on other non-opioid options is limited. Systemic lidocaine offers anti-inflammatory and opioid-sparing benefits and improves recovery in elective colorectal surgery, but its role in emergency laparotomy is still unclear and requires further study.

Conditions

Emergency Abdominal Surgery; Opioid Sparing Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Quality of recovery using QoR-15

  The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR)

  24 hours after surgery

Secondary Outcomes (8)

• intraoperative fentanyl consumption

  from time of induction of anesthesia until end of procedure

• mean arterial pressure

  at baseline preoperatively, every 10 minutes (averaging of each 5 readings) from induction of anesthesia until end of procedure, and 2, 6, 10, 16, 24 hours postoperatively.

• heart rate

  at baseline preoperatively, every 10 minutes (averaging of each 5 readings) from induction of anesthesia until end of procedure, and 2, 6, 10, 16, 24 hours postoperatively.

• postoperative opioid consumption

  from extubation until 24 hours postoperatively

• numeric rating scale

  30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively

Study Arms (2)

lidocaine group

ACTIVE COMPARATOR

lidocaine bolus at induction followed by infusion until the end of procedure

Drug: Lidocaine (drug)

Fentanyl group

ACTIVE COMPARATOR

fentanyl bolus at induction followed by saline infusion until the end of procedure

Drug: Fentanyl (IV)

Interventions

Lidocaine (drug) DRUG

induction bolus of 0.15 mL/kg of 10mg/ml lidocaine, followed by 0.15 mL/kg/h infusion (10 mg/mL lidocaine) until end of procedure

lidocaine group

Fentanyl (IV) DRUG

induction bolus of 0.15 mL/kg of 10mg/ml fentanyl, followed by 0.15 mL/kg/h infusion (saline) until end of procedure

Fentanyl group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (21-65 years), ASA I-III undergoing emergency laparotomy with midline incision

You may not qualify if:

• Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions)
• 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,
• Allergy of any of the study drugs
• Severe liver cell failure and renal impairment by history and/or abnormal liver and kidney function tests.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Pharmaceutical Preparations; Fentanyl

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Maha Mostafa, MD

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)