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Not yet recruitingNCT06889090O-S AnesthesiaUpdated Mar 26, 2025

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

An interventional study of : 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 and 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. in Anesthesia Recovery Period, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Anesthesia Recovery Period

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 332 are open to participants now.

This study's planned enrollment of 120 is below the median of 145 across 930 interventional studies indexed under Emergencies.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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,
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • 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.

  • DrugA 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.

06

What researchers measure

Primary outcomes

  1. - 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).

    Time frame: 24 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889090
Lead sponsor
Cairo University
Responsible party
Mai Madkour (Associate professor, Cairo University) — Principal investigator
First posted
Mar 21, 2025
Start date
Apr 20, 2025 (estimated)
Primary completion
Apr 30, 2026 (estimated)
Completion
May 12, 2026 (estimated)
Last update
Mar 26, 2025

Study contacts

Mai Madkour, Associate professor
Contact
maimadkour@kasralainy.edu.eg
+201223657694

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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