Post Operative Pain, AcuteEarly Phase 1NCT05150795
Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
A Early Phase 1 study testing Pregabalin 150mg and Fentanyl 100 micrograms ampoule in people with Post Operative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Pregabalin 150mg and Fentanyl 100 micrograms ampoule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Dec 2026
- Phase
- Early Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I
Who cannot join
- Patients' refusal
- use of sedatives, hypnotics, anti-psychotic or antidepressant drugs
- history of drug/alcohol abuse
- history of chronic pain
- daily intake of analgesics
- history of epilepsy
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
Ain-Shams University
Cairo
Ghada Mohamed Samir, MD, 01005043691 ext. 002, dr.ghada216@gmail.com
About this study
Official title: The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.
Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.
Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.
Read the detailed description
Our study aims to compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.
Patienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.
Also, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.
Patients will then be divided into 2 equal groups of 40 patients each:
Group P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.
Group F: Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Pregabalin 150mg, Fentanyl 100 micrograms ampoule
- Keywords
- pregabalin, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.
Fentanyl 100 micrograms ampouleDrug
Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group Pregabalin | Active comparator | Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia Receives: Drug: Pregabalin 150mg |
| Group Fentanyl | Active comparator | Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia Receives: Drug: Fentanyl 100 micrograms ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post-operative pain score at rest over time
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
Measured: 1 hour
Changes in post-operative pain score on coughing over time
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
Measured: 1 hour
Secondary outcomes (13)
Pre-operative level of patient sedation assessed by the sedation score
assessed 1 hour after administering the oral capsules by the sedation score from 0 to 4. 0=Awake and agitated, 1= Awake and comfortable, 2= Asleep and arousable, 3= Asleep with sluggish response to verbal commands or touch, 4= No response to verbal command or touch.
Measured: 1 hour
Duration of surgery
Measured in minutes
Measured: 2 hours
Duration of anesthesia
Measured in minutes
Measured: 3 hours
mean values of systolic blood pressure (SBP)
mean values of SBP at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 4 hours
Intra-operative additional doses of fentanyl given
Rescue analgesia needed in micrograms
Measured: 3 hours
Postoperative level of patient sedation
assessed by the sedation score from 0 to 4. 0=Awake and agitated, 1= Awake and comfortable, 2= Asleep and arousable, 3= Asleep with sluggish response to verbal commands or touch, 4= No response to verbal command or touch.
Measured: 1 hour
Post-operative pain score
at rest and on coughing using the Visual Analogue Score (VAS) score from 0 to 10 where 0= no pain and 10 is the worst pain felt. Pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
Measured: 12 hours
Pethidine requirements
Number of patients requiring pethidine in the PACU
Measured: 1 hour
sPO2
recorded in the induction room and in the PACU
Measured: 4 hours
changes in mean values of diastolic blood pressure (DBP)
mean values of DBP at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 4 hours
changes in mean values of mean blood pressure (MBP)
mean values of MBP,at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 4 hours
mean values of heart rate (HR)
mean values of HR at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 4 hours
total dose of pethidine given to the patient
total dose of pethidine given in milligrams will be recorded
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2022
- 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 Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150795
- Sponsor's protocol ID
- R18/2020/2021
- Status last verified
- Jan 2025
- First submitted
- 8 Oct 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
- ClinicalTrials.gov ID
- NCT05150795
- Acronym / sponsor ID
- R18/2020/2021
- Conditions
- Post Operative Pain, Acute
- Keywords
- pregabalin, analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Dec 2021 (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.
Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.
Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.
Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.
Detailed description
Our study aims to compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.
Patienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.
Also, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.
Patients will then be divided into 2 equal groups of 40 patients each:
Group P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.
Group F: Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Pregabalin | Active comparator | Drug: Pregabalin 150mgPatients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia |
| Group Fentanyl | Active comparator | Drug: Fentanyl 100 micrograms ampoulePatients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I
Key exclusion criteria (6 listed)
- Patients' refusal
- use of sedatives, hypnotics, anti-psychotic or antidepressant drugs
- history of drug/alcohol abuse
- history of chronic pain
- daily intake of analgesics
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 |
|---|---|---|
| Pregabalin 150mgCompare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery. | Drug | Group Pregabalin |
| Fentanyl 100 micrograms ampouleCompare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery. | Drug | Group Fentanyl |
Primary outcome
Changes in post-operative pain score at rest over time
Time frame: 1 hour
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
Changes in post-operative pain score on coughing over time
Time frame: 1 hour
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
13 secondary outcomes
Pre-operative level of patient sedation assessed by the sedation score
Time frame: 1 hour
Duration of surgery
Time frame: 2 hours
Duration of anesthesia
Time frame: 3 hours
mean values of systolic blood pressure (SBP)
Time frame: 4 hours
Intra-operative additional doses of fentanyl given
Time frame: 3 hours
Postoperative level of patient sedation
Time frame: 1 hour
Post-operative pain score
Time frame: 12 hours
Pethidine requirements
Time frame: 1 hour
sPO2
Time frame: 4 hours
changes in mean values of diastolic blood pressure (DBP)
Time frame: 4 hours
changes in mean values of mean blood pressure (MBP)
Time frame: 4 hours
mean values of heart rate (HR)
Time frame: 4 hours
total dose of pethidine given to the patient
Time frame: 12 hours
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Pregabalin 150mg and Fentanyl 100 micrograms ampoule in people with Post Operative Pain, Acute, run by Ain Shams 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 29 Jan 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ghada Mohamed Samir, MD (01005043691 ext. 002, dr.ghada216@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in post-operative pain score at rest over time (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 29 Jan 2025.