DacryocystitisNCT05455944
Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery
A study testing Pregabalin 150mg in people with Dacryocystitis, run by Sameh Fathy at 1 site in Egypt.
Trial summary
This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dacryocystitis
- What is being tested?
- Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 30 Dec 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for DCR surgery.
Who cannot join
- Patient' refusal of consent.
- Mental, psychological or neurological disorders.
- Patients with history of drug or alcohol abuse.
- History of know sensitivity to the used drugs.
- Bleeding or coagulation diathesis.
- Obese patients (body mass index (BMI) < 35).
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of PONV, in addition to effect on hemodynamic parameters between the two groups.
Read the detailed description
External dacryocystorhinostomy (DCR) is still considered the golden standard for lacrimal surgery. It is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. External DCR can be completed under either local or general anesthesia. It is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (PONV). So, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of PONV after DCR surgery.
Pregabalin is a lipophilic gamma-amino-butyric acid (GABA) analogue that binds to the voltage-gated calcium channels. It reduces the excitability of the dorsal horn neurons after tissue damage. It has anticonvulsant, anxiolytic and sleep-modulating properties. It was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury.
Preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption.
This study is a prospective randomized double-blind clinical trial included 100 ASA I and II patients of both sex with age between 18 and 65 years old, who are planned for elective DCR surgery under general anesthesia in Mansoura University ophthalmology center. Informed written consent is obtained from all subjects in the study after ensuring confidentiality. Details of the anesthetic technique and the study protocol are clarified to the entire involved cases. Patients are randomly assigned to two equal groups according to computer-generated randomization schedule.
A prospective analysis of the collected data is performed using the Statistical Package for the Social Sciences (SPSS) program for Windows (version 22). All data are considered statistically significant if P value is ≤ 0.05.
- Conditions
- Dacryocystitis
- Being tested
- Pregabalin 150mg, Placebo
- Keywords
- Pregabalin, Dacryocystorhinostomy, Analgesia
- Medical subject headings
- Dacryocystitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called Lyrica
Two capsules of pregabalin is administered orally to patients
PlaceboDrug
Also called Control
Two identical placebo capsules is administered orally to patients
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin Group | Active comparator | Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery Receives: Drug: Pregabalin 150mg |
| Control Group | Placebo comparator | Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain scores by visual analogue scale (VAS)
Pain (VAS) score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain)
Measured: Up to 24 hours after the procedure
Secondary outcomes (5)
Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
Measured: Up to the end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
Measured: Up to the end of the surgery
First analgesic request
The time of the first analgesic request for pethidine is recorded.
Measured: Up to 24 hours after the procedure
Total analgesic requirements of pethidine
The amount of pethidine consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Measured: Up to 24 hours after the procedure
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jan 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DacryocystitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Sameh M Elsherbiny, MD, Study director, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455944
- Sponsor's protocol ID
- Pregabalin in DCR surgery
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery
- ClinicalTrials.gov ID
- NCT05455944
- Acronym / sponsor ID
- Pregabalin in DCR surgery
- Conditions
- Dacryocystitis
- Keywords
- Pregabalin, Dacryocystorhinostomy, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 Jul 2022 (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.
This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of PONV, in addition to effect on hemodynamic parameters between the two groups.
Detailed description
External dacryocystorhinostomy (DCR) is still considered the golden standard for lacrimal surgery. It is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. External DCR can be completed under either local or general anesthesia. It is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (PONV). So, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of PONV after DCR surgery.
Pregabalin is a lipophilic gamma-amino-butyric acid (GABA) analogue that binds to the voltage-gated calcium channels. It reduces the excitability of the dorsal horn neurons after tissue damage. It has anticonvulsant, anxiolytic and sleep-modulating properties. It was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury.
Preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption.
This study is a prospective randomized double-blind clinical trial included 100 ASA I and II patients of both sex with age between 18 and 65 years old, who are planned for elective DCR surgery under general anesthesia in Mansoura University ophthalmology center. Informed written consent is obtained from all subjects in the study after ensuring confidentiality. Details of the anesthetic technique and the study protocol are clarified to the entire involved cases. Patients are randomly assigned to two equal groups according to computer-generated randomization schedule.
A prospective analysis of the collected data is performed using the Statistical Package for the Social Sciences (SPSS) program for Windows (version 22). All data are considered statistically significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin Group | Active comparator | Drug: Pregabalin 150mgPatients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery |
| Control Group | Placebo comparator | Drug: PlaceboPatients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for DCR surgery.
Key exclusion criteria (7 listed)
- Patient' refusal of consent.
- Mental, psychological or neurological disorders.
- Patients with history of drug or alcohol abuse.
- History of know sensitivity to the used drugs.
- Bleeding or coagulation diathesis.
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 150mgAlso: LyricaTwo capsules of pregabalin is administered orally to patients | Drug | Pregabalin Group |
| PlaceboAlso: ControlTwo identical placebo capsules is administered orally to patients | Drug | Control Group |
Primary outcome
Changes in pain scores by visual analogue scale (VAS)
Time frame: Up to 24 hours after the procedure
Pain (VAS) score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain)
5 secondary outcomes
Changes in heart rate
Time frame: Up to the end of the surgery
Changes in mean arterial blood pressure
Time frame: Up to the end of the surgery
First analgesic request
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of pethidine
Time frame: Up to 24 hours after the procedure
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 hours after the procedure
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 14 Jul 2022.
- 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. This study is not recruiting at the moment.
Sameh M Elsherbiny, MD study director
Mansoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 150mg in people with Dacryocystitis, run by Sameh Fathy 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 2 inclusion and 7 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 14 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
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?
Changes in pain scores by visual analogue scale (VAS) (time frame: Up to 24 hours after the procedure). 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 14 Jul 2022.