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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06889090
Acronym
O-S Anesthesia
Enrollment
120
Registered
2025-03-21
Start date
2025-04-20
Completion date
2026-05-12
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Recovery Period

Brief 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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
- Quality of recovery using the QoR-15 score 24 h after surgery.24 hours\- 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).

Contacts

Primary ContactMai Madkour, Associate professor
maimadkour@kasralainy.edu.eg+201223657694

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026