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.
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.
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.
- Conditions
- Post Operative Pain, Preemptive Analgesia
- 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 group | Role | What they receive |
|---|---|---|
| Paracetamol plus tramadol | Active comparator | Patients 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 |
| Fentanyl | Active comparator | Group 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.
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)
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.
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.
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.
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.
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.
- First posted14 Aug 2023
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Zagazig 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 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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Adel Shaker, Zagazig University
- Investigators
- MICHAEL A shaker, lecturer, Principal investigator, Zagazig University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05990686
- Acronym / sponsor ID
- ZU-IRB 459 /14-July 2024
- Conditions
- Post Operative Pain, Preemptive Analgesia
- Keywords
- Tramadol, Fentanyl, Paracetamol, Pre-emptive analgesia, Enhanced recovery after surgery, Day-case surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Aug 2023 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol plus tramadol | Active comparator | Drug: tramadol plus paracetamolPatients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia. |
| Fentanyl | Active comparator | Drug: Fentanyl InjectionGroup F received a single intravenous injection of fentanyl 1.5 µg/kg before induction. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| tramadol plus paracetamolAlso: tramadolPatients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia. | Drug | Paracetamol plus tramadol |
| Fentanyl InjectionGroup F received a single intravenous injection of fentanyl 1.5 µg/kg before induction. | Drug | Fentanyl |
Primary outcome
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 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.
5 secondary outcomes
Postoperative pain intensity
Time frame: On arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.
Rescue analgesic
Time frame: From arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.
Postoperative sedation/agitation
Time frame: After extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.
Mean arterial blood pressure
Time frame: Baseline (preoperatively) and on arrival to the recovery room postoperatively.
Heart Rate
Time frame: Baseline (preoperatively) and on arrival to the recovery room postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
MICHAEL A shaker, lecturer principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
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.