Effect of Opioid-sparing 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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergency Abdominal Surgery; Opioid Sparing Anaesthesia
• Intervention / Treatment: Drug: Lidocaine (drug); Drug: Fentanyl (IV)

Detailed Description

Upon arrival to the operating room, routine monitors will be applied; intravenous line will be secured, and 8 mg dexamethasone will be slowly administrated. Baseline preoperative blood pressure will be recorded as the average of three readings with difference less than 5 mmHg.

Preoperative fluid management Fluid responsiveness will be defined as a 10% increase in stroke volume after passive leg raising maneuver. Fluid responder will be given 500-mL bolus of lactated ringer. Passive leg raising will be repeated until wither the patient is non-responder or 1500 mL were infused.

induction of anesthesia: 2 mg/kg propofol and 1 mg/kg succinyl choline. Anesthesia will be maintained by isoflurane in air/oxygen admixture (with target end tidal isoflurane 1-1.2%). Atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg and then regularly according to local protocols.

A 10-12 mL/kg/hr of lactated ringer will be infused during the procedure. Heart rate and blood pressure will be monitored at 2 min intervals. The average of every 5 successive readings would be recorded every 10 min. If patients developed hypotension (mean arterial pressure (MAP) ≤ 70% of the baseline reading and/or <65 mmHg), a fluid bolus of 4 mL/kg will be given and the change in the pulse pressure will be noted. If the pulse pressure increases by >10 %, the fluid bolus will be given until the increase in pulse pressure is <10%. If hypotension persists despite the adequate volume replacement a 5-mcg bolus of norepinephrine will be given. The bolus will be repeated if MAP was not restored within 2 min. Infusion of norepinephrine can be given if MAP persisted <65 mmHg despite 5 boluses of norepinephrine.

If bradycardia occurred (defined as heart rate less than 55 bpm), it will be managed by IV atropine bolus (0.5 mg).

Intraoperative tachycardia and/or hypertension (defined as 20% increase from the baseline value) will be managed by fentanyl bolus of 0.5 mcg/kg, in absence of other causes.

At the end of the procedure, all patients will receive 1 gm of paracetamol intravenously and local infiltration of the wound with 40 mL of 0.125% bupivacaine. Patients who are not indicated for extubation at the end of the surgery will be excluded from the study.

Postoperative management All patients will receive 1 gm/ 6h of paracetamol. Static (at rest) and dynamic (during cough) numerical rating scale (NRS) will be assessed at 0.5, 2, 6, 10, 16, 24 hr postoperatively. If the NRS>3, a 2 mg morphine bolus will be given to be repeated after 30 min if pain persists.

4 mg of ondansetron will be given if patients developed nausea or vomiting.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa, MD; Phone Number: +201000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy Hospital
    • Contact: Ahmed Hasanin; Phone Number: 01095076954; Email: ahmedmohamedhasanin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (21-65 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)
• 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,
• Allergy of any of the study drugs
• Severe liver cell failure and renal impairment by history and/or abnormal liver and kidney function tests.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lidocaine group; lidocaine bolus at induction followed by infusion until the end of procedure	Drug: Lidocaine (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
Active Comparator: Fentanyl group; fentanyl bolus at induction followed by saline infusion until the end of procedure	Drug: Fentanyl (IV); induction bolus of 0.15 mL/kg of 10mg/ml fentanyl, followed by 0.15 mL/kg/h infusion (saline) until end of procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative fentanyl consumption	mcg/kg	from time of induction of anesthesia until end of procedure
mean arterial pressure	mmHg	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.
heart rate	bpm	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.
postoperative opioid consumption	nalbuphine in mg	from extubation until 24 hours postoperatively
numeric rating scale	rate pain on a scale of 0-10, 0: no pain, 10: worst pain	30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively
serum lactate		30 minutes postoperative
respiratory rate		30 minutes postoperative
Oxygen saturation/ fraction of inspired oxygen (SF ratio)		30 minutes postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Lidocaine; Fentanyl; Pharmaceutical Preparations
• Other Study ID Numbers: MD-5-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data related to this research are available from the PI upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No