Post-operative AnalgesiaNCT03603626
Preemptive Pregabalin in Myringoplasty
A study testing Pregabalin 150mg in people with Post-operative Analgesia and CSOM - Chronic Suppurative Otitis Media, run by Dhulikhel Hospital at 1 site in Nepal.
Trial summary
The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-operative Analgesia, CSOM - Chronic Suppurative Otitis Media
- What is being tested?
- Pregabalin 150mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNepal
- Study dates
- Sep 2015to Dec 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
- Age >= 18 years
- either sex.
Who cannot join
- Revision cases,
- Pregnancy or breastfeeding,
- Known or suspected sensitivity or contraindication to pregabalin,
- Patient using medication for chronic pain,
- History of seizure disorder,
- Mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty
The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.
Read the detailed description
Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery.
All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it.
Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.
- Being tested
- Pregabalin 150mg, Placebo oral capsule
- Keywords
- Endoscopic ear surgery, Myringoplasty, Pregabalin, Preemptive analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Preemptive pregabalin 150 mg administered 1 hour before surgery
Placebo oral capsuleDrug
Also called Vitamin B capsule
Placebo administered 1 hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| Preemptive pregabalin | Experimental | Not described Receives: Drug: Pregabalin 150mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.
Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. VAS score was compared between 2 groups at 6, 12, 24, 48 hrs post-operative period. This would show if there is any change in pain score between groups using pregabalin or placebo in the given time frame.
Measured: At 6, 12, 24, 48 hours in postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative AnalgesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhulikhel Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Responsible party
- Principal investigator, Dr Ashish Dhakal, Dhulikhel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603626
- Sponsor's protocol ID
- 13/18
- Status last verified
- Sep 2018
- First submitted
- 7 Jul 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty
- ClinicalTrials.gov ID
- NCT03603626
- Acronym / sponsor ID
- 13/18
- Keywords
- Endoscopic ear surgery, Myringoplasty, Pregabalin, Preemptive analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dhulikhel HospitalUniversity, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Jul 2018 (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.
The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.
Detailed description
Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery.
All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it.
Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preemptive pregabalin | Experimental | Drug: Pregabalin 150mg |
| Placebo | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
- Age >= 18 years
- either sex.
Key exclusion criteria (6 listed)
- Revision cases,
- Pregnancy or breastfeeding,
- Known or suspected sensitivity or contraindication to pregabalin,
- Patient using medication for chronic pain,
- History of seizure disorder,
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 150mgPreemptive pregabalin 150 mg administered 1 hour before surgery | Drug | Preemptive pregabalin |
| Placebo oral capsuleAlso: Vitamin B capsulePlacebo administered 1 hour before surgery | Drug | Placebo |
Primary outcome
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.
Time frame: At 6, 12, 24, 48 hours in postoperative period
Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. VAS score was compared between 2 groups at 6, 12, 24, 48 hrs post-operative period. This would show if there is any change in pain score between groups using pregabalin or placebo in the given time frame.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Post-operative Analgesia and CSOM - Chronic Suppurative Otitis Media, run by Dhulikhel Hospital at 1 site in Nepal.
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 3 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: withdrawn, as of the sponsor's last update on 24 Sep 2018. 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 Nepal. 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 was withdrawn before enrolling participants, so there are no results.
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?
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty. (time frame: At 6, 12, 24, 48 hours in postoperative period). 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 24 Sep 2018.