Emergency Abdominal SurgeryNCT07262242
Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy
A study testing Lidocaine (drug) and Fentanyl (IV) in people with Emergency Abdominal Surgery and Opioid Sparing Anaesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Emergency Abdominal Surgery, Opioid Sparing Anaesthesia
- What is being tested?
- Lidocaine (drug) and Fentanyl (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (21-65 years), ASA I-III undergoing emergency laparotomy with midline incision
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Hospital
Cairo, 11562
Ahmed Hasanin, 01095076954, ahmedmohamedhasanin@gmail.com
About this study
Official title: 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.
Read the detailed description
preoperatively, 8 mg dexamethasone will be slowly administrated. Fluid responsiveness will be defined as a 10% increase in stroke volume after passive leg raising maneuver. If responder will be given 500-mL bolus of lactated ringer.
induction of anesthesia: 2 mg/kg propofol and 1 mg/kg succinyl choline. Anesthesia will be maintained by isoflurane in air/oxygen admixture. Atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg.
A 10-12 mL/kg/hr of lactated ringer will be infused during the procedure. 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 5-10 mg bolus of ephedrine 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.
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.
Postoperative management All patients will receive 1 gm/ 6h of paracetamol.
- Being tested
- Lidocaine (drug), Fentanyl (IV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Active comparator | lidocaine bolus at induction followed by infusion until the end of procedure Receives: Drug: Lidocaine (drug) |
| Fentanyl group | Active comparator | fentanyl bolus at induction followed by saline infusion until the end of procedure Receives: Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours after surgery
Secondary outcomes (8)
intraoperative fentanyl consumption
mcg/kg
Measured: from time of induction of anesthesia until end of procedure
mean arterial pressure
mmHg
Measured: 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
Measured: 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
Measured: from extubation until 24 hours postoperatively
numeric rating scale
rate pain on a scale of 0-10, 0: no pain, 10: worst pain
Measured: 30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively
serum lactate
Measured: 30 minutes postoperative
respiratory rate
Measured: 30 minutes postoperative
Oxygen saturation/ fraction of inspired oxygen (SF ratio)
Measured: 30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start4 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262242
- Sponsor's protocol ID
- MD-5-2025
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data related to this research are available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07262242
- Acronym / sponsor ID
- MD-5-2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
preoperatively, 8 mg dexamethasone will be slowly administrated. Fluid responsiveness will be defined as a 10% increase in stroke volume after passive leg raising maneuver. If responder will be given 500-mL bolus of lactated ringer.
induction of anesthesia: 2 mg/kg propofol and 1 mg/kg succinyl choline. Anesthesia will be maintained by isoflurane in air/oxygen admixture. Atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg.
A 10-12 mL/kg/hr of lactated ringer will be infused during the procedure. 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 5-10 mg bolus of ephedrine 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.
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.
Postoperative management All patients will receive 1 gm/ 6h of paracetamol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Active comparator | Drug: Lidocaine (drug)lidocaine bolus at induction followed by infusion until the end of procedure |
| Fentanyl group | Active comparator | Drug: Fentanyl (IV)fentanyl bolus at induction followed by saline infusion until the end of procedure |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (21-65 years), ASA I-III undergoing emergency laparotomy with midline incision
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | lidocaine group |
| 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 | Drug | Fentanyl group |
Primary outcome
Quality of recovery using QoR-15
Time frame: 24 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR)
8 secondary outcomes
intraoperative fentanyl consumption
Time frame: from time of induction of anesthesia until end of procedure
mean arterial pressure
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.
heart rate
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.
postoperative opioid consumption
Time frame: from extubation until 24 hours postoperatively
numeric rating scale
Time frame: 30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively
serum lactate
Time frame: 30 minutes postoperative
respiratory rate
Time frame: 30 minutes postoperative
Oxygen saturation/ fraction of inspired oxygen (SF ratio)
Time frame: 30 minutes postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. data related to this research are available from the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine (drug) and Fentanyl (IV) in people with Emergency Abdominal Surgery and Opioid Sparing Anaesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Mostafa, MD (+201000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery using QoR-15 (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.