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

ConditionsEmergency Abdominal SurgeryOpioid Sparing Anaesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (21-65 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)

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

  • 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

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: lidocaine groupActive comparator 1 intervention
Group B: Fentanyl groupActive comparator 1 intervention

Trial outcomes

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)

Time frame
24 hours after surgery

Secondary outcomes

1

intraoperative fentanyl consumption

mcg/kg

Time frame
from time of induction of anesthesia until end of procedure
2

mean arterial pressure

mmHg

Time frame
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.
3

heart rate

bpm

Time frame
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.
4

postoperative opioid consumption

nalbuphine in mg

Time frame
from extubation until 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: