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Post Operative PainPhase 4NCT05990686

Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

A Phase 4 study testing tramadol plus paracetamol and Fentanyl Injection in people with Post Operative Pain and Preemptive Analgesia, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Post Operative Pain, Preemptive Analgesia
What is being tested?
tramadol plus paracetamol and Fentanyl Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteEgypt
Study dates
1 Jun 2025to 31 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for day case surgeries.
  • Patient's age: 21-65 years.
  • Patients with ASA physical status I, II.
  • BMI 25 - 30 25-30 kg/m²

Who cannot join

  • Uncooperative patients
  • Patients with psychological problems
  • Patients with liver or renal impairment
  • Patients with a history of allergy to the drugs used in the study
  • Patients with chronic pain and current use of analgesic therapy for a pre-existing condition
  • Patients who did not fulfill the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Zagazig University , Fuculty of Medicine

    Zagazig, Sharquia, 7120730

Other trials in Egypt

About this study

Official title: Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial

Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.

Multiple analgesic strategies have been proposed including NSAID, opioids, epidural analgesia. Each of them has its limitations.

In this study the investigators will compare the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Read the detailed description

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameters will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.

Patients will be randomly allocated into two equal groups:

  • Group (T) (n=51): Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and finished before the start of induction of anesthesia
  • Group ( F ) (n=51): Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient before induction.

Both groups will be induced with propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation and maintained with inhaled isoflurane and incremental doses of muscle relaxant if needed. Neuromuscular blockade will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg.

In both groups intraoperative monitoring of heart rate (beats/min) and mean arterial blood pressure (mmHg) will be documented.

Postoperatively:

In the recovery room and in the surgical ward the patient's mean blood pressure and heart rate will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also, the postoperative pain assessment for all patients will be done by an anesthesiologist (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on the visual analog scale (VAS) (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. A Quality of Recovery questionnaire (QoR-40) will be administered 24 hours postoperatively by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.

Rescue analgesia (intravenous Ketorolac 30 mg) was administered if tachycardia and/or hypertension occurred postoperatively, defined as an increase in heart rate or blood pressure of more than 25 % from baseline, or if the VAS score was 5 or higher. Time to first request for postoperatiev rescue analgesia will be recorded.

Rescue antiemetics (Ondansetron 8 mg) will be given to any patient complaining of nausea and vomiting, occurrence of other side effects including bradycardia or hypotension will be recorded and managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20% of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of ephedrine. Bradycardia, defined as a heart rate below 50 beats/min, will be managed with atropine 0.2-0.5 mg. Patient satisfaction, postoperative sedation/agitation using the Richmod Agitation-Sedation Scale (RASS), and length of postoperative hospital stay will also be recorded.

Being tested
tramadol plus paracetamol, Fentanyl Injection
Keywords
Tramadol, Fentanyl, Paracetamol, Pre-emptive analgesia, Enhanced recovery after surgery, Day-case surgery
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tramadol plus paracetamolDrug

    Also called tramadol

    Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.

  • Fentanyl InjectionDrug

    Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.

Study groups in NCT05990686
Study groupRoleWhat they receive
Paracetamol plus tramadolActive comparatorPatients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.
Receives: Drug: tramadol plus paracetamol
FentanylActive comparatorGroup F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.
Receives: Drug: Fentanyl Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enhanced Recovery Score

    It will be derived from the 40-item Quality of Recovery questionnaire (QoR-40), which assesses five dimensions of postoperative recovery: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 40 items is scored from 1 (worst) to 5 (best), yielding a total score ranging from 40 to 200.

    Measured: The QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.

Secondary outcomes (5)
  1. Postoperative pain intensity

    It will be assessed using the 10 cm visual analogue scale (VAS; 0 = no pain, 10 = worst pain imaginable) and the patient was instructed to mark along the line which pain intensity is currently being experienced.

    Measured: On arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.

  2. Rescue analgesic

    Document the first time for the need of rescue analgesia.

    Measured: From arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.

  3. Postoperative sedation/agitation

    Will be assessed using the Richmond Agitation-Sedation Scale (RASS).

    Measured: After extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.

  4. Mean arterial blood pressure

    Compare mean arterial blood pressure (mmHg) between patients in both groups.

    Measured: Baseline (preoperatively) and on arrival to the recovery room postoperatively.

  5. Heart Rate

    Compare the heart rate (beats/min) between patients in both groups.

    Measured: Baseline (preoperatively) and on arrival to the recovery room postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990686
Sponsor's protocol ID
ZU-IRB 459 /14-July 2024
Status last verified
Sep 2026
First submitted
29 Jul 2023
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tramadol plus paracetamol and Fentanyl Injection in people with Post Operative Pain and Preemptive Analgesia, run by Zagazig 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 4 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: finished, as of the sponsor's last update on 15 Sep 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enhanced Recovery Score (time frame: The QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.). 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 15 Sep 2026.

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