Pain, NervePhase 4NCT04653792

Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

A Phase 4 study testing Pregabalin 75mg in people with Pain, Nerve and Prolapsed Intervertebral Disc, run by Ziauddin University at 1 site in Pakistan.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Pain, Nerve, Prolapsed Intervertebral Disc
What is being tested?: Pregabalin 75mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 sitePakistan
Study dates: 4 Jun 2018to 17 Apr 2020
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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients with severe CLBP and/or leg pain
Patients with static or dynamic leg pain
Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)

Who cannot join

Patients with previous lumbar surgery
Patients allergic to gabapentinoids
Patients with renal impairments
Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
Patient presented with diabetes and other drugs that depress the central nervous system
Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Dr. Ziauddin University Hospital Clifton Campus
Karachi, Sindh, 75600

Other trials in Pakistan

About this study

Official title: Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial

Read the detailed description

All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.

Conditions: Pain, Nerve, Prolapsed Intervertebral Disc
Being tested: Pregabalin 75mg, Placebo
Keywords: Microdiscectomy, Pregabalin
Medical subject headings: Neuralgia, Intervertebral Disc Displacement

What participants receive

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

Pregabalin 75mgDrug
Also called Lyrica (Pregabalin) 75mg
75 mg capsule
PlaceboDevice
Also called Pregabalin placebo
75 mg

Study groups in NCT04653792
Study group	Role	What they receive
Pregabalin	Experimental	Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative Receives: Drug: Pregabalin 75mg
Pregabalin Placebo	Placebo comparator	Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative Receives: Device: Placebo

What is being measured

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

change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
VAS pain scale is a validated, self-reported instrument assessing average pain intensity over the past 24 hours period. Possible scores being 0 (no pain) and 10 (worst possible pain). Change = (1 week post surgery - preoperative pain)
Measured: Preoperative and one week postoperative

Timeline

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

4 Jun 201817 Apr 2020

First posted4 Dec 2020
Study start4 Jun 2018
Primary completion17 Apr 2020
Study completion17 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, NerveStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04653792
Sponsor's protocol ID: preg2020micro
Status last verified: Dec 2020
First submitted: 27 Nov 2020
Last updated: 4 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Not yet recruiting
Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain
Knee Osteoarthritis, Chronic Knee Pain
Not yet recruiting
Pudendal Nerve Block for Pain Relief During Episiotomy Repair
Episiotomy , Perineal Pain
Active, not recruitingPhase 1/2
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
Neurofibromatosis 1, Neurofibromatosis Type 1

All Pain, Nerve trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04653792
Acronym / sponsor ID: preg2020micro
Conditions: Pain, Nerve, Prolapsed Intervertebral Disc
Keywords: Microdiscectomy, Pregabalin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Ziauddin UniversityUniversity, hospital or other
Study start: 4 Jun 2018 (actual)
Primary completion: 17 Apr 2020 (actual)
Study completion: 17 Apr 2020 (actual)
First posted: 4 Dec 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pregabalin	Experimental	Drug: Pregabalin 75mgParticipants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
Pregabalin Placebo	Placebo comparator	Device: PlaceboParticipants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

All patients with severe CLBP and/or leg pain
Patients with static or dynamic leg pain
Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)

Key exclusion criteria (6 listed)

Patients with previous lumbar surgery
Patients allergic to gabapentinoids
Patients with renal impairments
Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
Patient presented with diabetes and other drugs that depress the central nervous system

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 75mgAlso: Lyrica (Pregabalin) 75mg75 mg capsule	Drug	Pregabalin
PlaceboAlso: Pregabalin placebo75 mg	Device	Pregabalin Placebo

Primary outcome

change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
Time frame: Preoperative and one week postoperative
VAS pain scale is a validated, self-reported instrument assessing average pain intensity over the past 24 hours period. Possible scores being 0 (no pain) and 10 (worst possible pain). Change = (1 week post surgery - preoperative pain)

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 4 Dec 2020.
Individual participant dataSharing planned: No

Related trials for Pain, Nerve

Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Not yet recruiting
Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain
Knee Osteoarthritis, Chronic Knee Pain
Not yet recruiting
Pudendal Nerve Block for Pain Relief During Episiotomy Repair
Episiotomy , Perineal Pain
Active, not recruitingPhase 1/2
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
Neurofibromatosis 1, Neurofibromatosis Type 1

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.

Shahzaib Riaz principal investigator

Ziauddin University hospital Karachi

Sohail Rafi, FCPS study director

Ziauddin University Hospital Karachi

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 Pregabalin 75mg in people with Pain, Nerve and Prolapsed Intervertebral Disc, run by Ziauddin University at 1 site in Pakistan.

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 4 Dec 2020. 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 Pakistan. 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.

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?

change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID (time frame: Preoperative and one week postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04653792.

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 4 Dec 2020.