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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-20

Study Completion Date

2026-05-12

Brief Summary

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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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Detailed Description

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Conditions

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Anesthesia Recovery Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

: 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

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

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.

Intervention Type 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

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: 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No