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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (18-65 years)

ASA I-III undergoing emergency laparotomy with midline incision.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • : 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

    : 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.

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: opioid sparingActive comparator 1 intervention
Group B: conventionalPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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