Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy
NCT ID: NCT00954187
Last Updated: 2017-01-09
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
8 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-11-30
Study Completion Date
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK).
Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK.
Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented.
Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.
Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK.
Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented.
Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
NCT01177514
Pain After Photorefractive Keratectomy
COMPLETED
PHASE4
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
NCT00793910
Postoperative Pain
COMPLETED
NA
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
NCT01122004
Refractive Errors
UNKNOWN
PHASE1
A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
NCT01097577
Postoperative Pain
COMPLETED
NA
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
NCT02957097
Pain, Postoperative
Acute Pain
Facial Pain
WITHDRAWN
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
METHODS:
One hundred and four patients who meet the inclusion criteria undergoing photorefractive keratectomy (PRK) in one or both eyes will be randomly assigned into one of two treatment groups via computer. Those in group A will be treated with gabapentin and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery. Patients in the gabapentin group will take 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days. Patients in the pregabalin group will take 50 mg three times a day starting two hours prior to surgery and will also continue for four days.
Only the refractive surgery coordinator and the patient will know what medication the patient is taking. The patient will be instructed not to share this information with any other study participants or their surgeon. The coordinator will keep a list of the patients ID numbers and the treatments they are receiving.
Prior to surgery, each patient will be taught how to assess their pain level using the visual analogue scale (VAS), a well documented method of pain assessment. After surgery the patients will assess their pain levels at different intervals of time - one hour after surgery, the evening of the surgery, and three times a day for four subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness daily for the same amount of time. On the fourth day they will return to clinic for a post operative appointment. At that time the pain assessment scales will be collected and analyzed. The patients will return at one month to further assess long term pain after PRK.
Statistical Analysis:
Postoperative pain levels recorded using the visual analogue scales, ESS, and self reported dizziness assessments will be collected on the fourth postoperative day. These will be compiled into data sets and analyzed. Data will be compiled into means with lower and upper quartiles and analyzed using a two-sided t test. The difference in pain levels will be described throughout the postoperative period to determine if one medication significantly reduces postoperative pain initially within the first 24 hours, during the interval between 24 hours to four days, and further after surgery (one month postoperatively). Data regarding levels of somnolence and dizziness will also be reported.
One hundred and four patients who meet the inclusion criteria undergoing photorefractive keratectomy (PRK) in one or both eyes will be randomly assigned into one of two treatment groups via computer. Those in group A will be treated with gabapentin and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery. Patients in the gabapentin group will take 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days. Patients in the pregabalin group will take 50 mg three times a day starting two hours prior to surgery and will also continue for four days.
Only the refractive surgery coordinator and the patient will know what medication the patient is taking. The patient will be instructed not to share this information with any other study participants or their surgeon. The coordinator will keep a list of the patients ID numbers and the treatments they are receiving.
Prior to surgery, each patient will be taught how to assess their pain level using the visual analogue scale (VAS), a well documented method of pain assessment. After surgery the patients will assess their pain levels at different intervals of time - one hour after surgery, the evening of the surgery, and three times a day for four subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness daily for the same amount of time. On the fourth day they will return to clinic for a post operative appointment. At that time the pain assessment scales will be collected and analyzed. The patients will return at one month to further assess long term pain after PRK.
Statistical Analysis:
Postoperative pain levels recorded using the visual analogue scales, ESS, and self reported dizziness assessments will be collected on the fourth postoperative day. These will be compiled into data sets and analyzed. Data will be compiled into means with lower and upper quartiles and analyzed using a two-sided t test. The difference in pain levels will be described throughout the postoperative period to determine if one medication significantly reduces postoperative pain initially within the first 24 hours, during the interval between 24 hours to four days, and further after surgery (one month postoperatively). Data regarding levels of somnolence and dizziness will also be reported.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Postoperative Pain
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gabapentin
Neurontin
Group Type
EXPERIMENTAL
Gabapentin
Intervention Type
DRUG
Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
Pregabalin
Lyrica
Group Type
EXPERIMENTAL
pregabalin
Intervention Type
DRUG
50 mg PO TID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gabapentin
Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
Intervention Type
DRUG
pregabalin
50 mg PO TID
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Neurontin
Lyrica
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years of age or older
* Undergoing PRK in at least one eye
* Undergoing PRK in at least one eye
Exclusion Criteria
* Serious medical problems within the last 6 months including myocardial infarction (heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary embolism, and other conditions, etc.
* Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
* History of seizure or other neurologic disorders.
* Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
* Currently taking gabapentin or pregabalin for other medical purposes.
* Known allergic reaction to gabapentin or pregabalin from previous use.
* Plans to move out of the area within 8 weeks after the surgery.
* Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
* History of seizure or other neurologic disorders.
* Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
* Currently taking gabapentin or pregabalin for other medical purposes.
* Known allergic reaction to gabapentin or pregabalin from previous use.
* Plans to move out of the area within 8 weeks after the surgery.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Loma Linda University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julio Narvaez, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loma Linda University - Ophthalmology
Loma Linda, California, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Shortt AJ, Allan BD. Photorefractive keratectomy (PRK) versus laser-assisted in-situ keratomileusis (LASIK) for myopia. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005135. doi: 10.1002/14651858.CD005135.pub2.
Reference Type
BACKGROUND
Ambrosio R Jr, Wilson S. LASIK vs LASEK vs PRK: advantages and indications. Semin Ophthalmol. 2003 Mar;18(1):2-10. doi: 10.1076/soph.18.1.2.14074.
Reference Type
BACKGROUND
Lee JB, Kim JS, Choe C, Seong GJ, Kim EK. Comparison of two procedures: photorefractive keratectomy versus laser in situ keratomileusis for low to moderate myopia. Jpn J Ophthalmol. 2001 Sep-Oct;45(5):487-91. doi: 10.1016/s0021-5155(01)00406-3.
Reference Type
BACKGROUND
Van de Pol C, Greig JL, Estrada A, Bissette GM, Bower KS. Visual and flight performance recovery after PRK or LASIK in helicopter pilots. Aviat Space Environ Med. 2007 Jun;78(6):547-53.
Reference Type
BACKGROUND
Walker MB, Wilson SE. Recovery of uncorrected visual acuity after laser in situ keratomileusis or photorefractive keratectomy for low myopia. Cornea. 2001 Mar;20(2):153-5. doi: 10.1097/00003226-200103000-00007.
Reference Type
BACKGROUND
Sandoval HP, de Castro LE, Vroman DT, Solomon KD. Refractive Surgery Survey 2004. J Cataract Refract Surg. 2005 Jan;31(1):221-33. doi: 10.1016/j.jcrs.2004.08.047.
Reference Type
BACKGROUND
Hazelrigg SR, Auer JE, Seifert PE. Experience in 100 transthoracic balloon pumps. Ann Thorac Surg. 1992 Sep;54(3):528-32. doi: 10.1016/0003-4975(92)90448-d.
Reference Type
BACKGROUND
Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
Reference Type
BACKGROUND
Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.
Reference Type
BACKGROUND
Pandey CK, Navkar DV, Giri PJ, Raza M, Behari S, Singh RB, Singh U, Singh PK. Evaluation of the optimal preemptive dose of gabapentin for postoperative pain relief after lumbar diskectomy: a randomized, double-blind, placebo-controlled study. J Neurosurg Anesthesiol. 2005 Apr;17(2):65-8. doi: 10.1097/01.ana.0000151407.62650.51.
Reference Type
BACKGROUND
Turan A, Karamanlioglu B, Memis D, Hamamcioglu MK, Tukenmez B, Pamukcu Z, Kurt I. Analgesic effects of gabapentin after spinal surgery. Anesthesiology. 2004 Apr;100(4):935-8. doi: 10.1097/00000542-200404000-00025.
Reference Type
BACKGROUND
Turan A, Memis D, Karamanlioglu B, Yagiz R, Pamukcu Z, Yavuz E. The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. Anesth Analg. 2004 Aug;99(2):375-8, table of contents. doi: 10.1213/01.ANE.0000136646.11737.7B.
Reference Type
BACKGROUND
Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.
Reference Type
BACKGROUND
Kavalieratos CS, Dimou T. Gabapentin therapy for painful, blind glaucomatous eye: case report. Pain Med. 2008 Apr;9(3):377-8. doi: 10.1111/j.1526-4637.2006.00167.x.
Reference Type
BACKGROUND
Poujois A, Vidailhet M, Trocello JM, Bourdain F, Gaymard B, Rivaud-Pechoux S. Effect of gabapentin on oculomotor control and parkinsonism in patients with progressive supranuclear palsy. Eur J Neurol. 2007 Sep;14(9):1060-2. doi: 10.1111/j.1468-1331.2007.01687.x.
Reference Type
BACKGROUND
Rahman W, Proudlock F, Gottlob I. Oral gabapentin treatment for symptomatic Heimann-Bielschowsky phenomenon. Am J Ophthalmol. 2006 Jan;141(1):221-2. doi: 10.1016/j.ajo.2005.08.022.
Reference Type
BACKGROUND
Choudhuri I, Sarvananthan N, Gottlob I. Survey of management of acquired nystagmus in the United Kingdom. Eye (Lond). 2007 Sep;21(9):1194-7. doi: 10.1038/sj.eye.6702434. Epub 2006 May 26.
Reference Type
BACKGROUND
Nissman SA, Tractenberg RE, Babbar-Goel A, Pasternak JF. Oral gabapentin for the treatment of postoperative pain after photorefractive keratectomy. Am J Ophthalmol. 2008 Apr;145(4):623-629. doi: 10.1016/j.ajo.2007.11.012. Epub 2008 Jan 28.
Reference Type
BACKGROUND
Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
Reference Type
BACKGROUND
Taylor CP. Mechanisms of analgesia by gabapentin and pregabalin--calcium channel alpha2-delta [Cavalpha2-delta] ligands. Pain. 2009 Mar;142(1-2):13-6. doi: 10.1016/j.pain.2008.11.019. Epub 2009 Jan 6. No abstract available.
Reference Type
BACKGROUND
Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87.
Reference Type
BACKGROUND
Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004 Dec 14;63(11):2104-10. doi: 10.1212/01.wnl.0000145767.36287.a1.
Reference Type
BACKGROUND
Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005 Apr;6(4):253-60. doi: 10.1016/j.jpain.2004.12.007.
Reference Type
BACKGROUND
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Reference Type
BACKGROUND
Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
Reference Type
BACKGROUND
Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
59070
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Preanalgesic Effect of Gabapentin in Total Knee Repair
NCT00279487
COMPLETED
NA
Effects of Perioperative Pregabalin for Post-Craniotomy Pain
NCT01591980
WITHDRAWN
PHASE4
Management of Pain Associated With Failed Back Surgery Syndrome
NCT05324761
COMPLETED
PHASE4
Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
NCT05150795
RECRUITING
EARLY_PHASE1
Comparison of Gabapentin and Pregabalin for Radicular Pain
NCT02064790
COMPLETED
Pregabalin vs. Gabapentin on Reducing Opioid Usage
NCT04705480
COMPLETED
PHASE4
Effect of Gabapentin on Orthopedic Pain
NCT01546857
TERMINATED
PHASE4
Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.
NCT03905486
COMPLETED
NA
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
NCT03241875
COMPLETED
PHASE4
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
NCT00735124
TERMINATED
PHASE2/PHASE3
Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints
NCT02238717
COMPLETED
PHASE1
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
NCT01014520
UNKNOWN
PHASE2
Pregabalin Versus Gabapentin Opioid Sparing Effect in Discectomy
NCT05539924
UNKNOWN
PHASE3
Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
NCT03714867
WITHDRAWN
PHASE4
Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
NCT02120703
COMPLETED
PHASE3
The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty
NCT05071118
COMPLETED
PHASE4
Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
NCT00729690
COMPLETED
PHASE3
Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
NCT01112878
WITHDRAWN
PHASE4
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
NCT00468845
COMPLETED
PHASE3
Pregabalin for Post-craniotomy Pain Control
NCT01612832
UNKNOWN
NA
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
NCT04700592
COMPLETED
NA
Gabapentin Regimens and Their Effects on Opioid Consumption
NCT03334903
COMPLETED
PHASE4
Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy
NCT05609682
COMPLETED
EARLY_PHASE1
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
NCT04265456
COMPLETED
PHASE1
Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
NCT00558753
COMPLETED
PHASE2