Pain, PostoperativePhase 1NCT03498261
A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
A Phase 1 study testing Gabapentin in people with Pain, Postoperative and Opioid Use, run by Ohio State University at 1 site in United States.
Trial summary
Adding a single preoperative dose of gabapentin to the standard pain regimen will reduce postoperative opioid consumption within the first 72 hours in patients undergoing rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 30 Dec 2027
- Phase
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients males and females ≥ 18 years old
- Patients providing a written informed consent in English language
- Patients scheduled to undergo rhinoplasty under general endotracheal anesthesia
Who cannot join
- Patients with known allergies to medications described in this study: acetaminophen, gabapentin, and opioids (morphine, fentanyl, hydromorphone, oxycodone)
- Patients with chronic use of opioids due to any medical/surgical condition or those receiving any opioid medication within the 48 hours before surgery
- Use of gabapentin and/or pregabalin within the last 14 days prior to surgery
- Use of acetaminophen within the last 7 days prior to surgery
- Hepatic disease as documented in patient past medical history
- Medical history of autoimmune/neurodegenerative disease
Show all 10Show fewer
- Pregnancy or breast feeding
- Patients with history of alcohol or substance abuse/dependency within the last 6 months
- Patients with previous participation in this study or receiving any investigational product within the last 30 days
- Patients under legal protection or prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Adding a single preoperative dose of gabapentin to the standard pain regimen will reduce postoperative opioid consumption within the first 72 hours in patients undergoing rhinoplasty.
Read the detailed description
Study Design A prospective randomized double blind study will be conducted to assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty at The Ohio State University Wexner Medical Center.
Preoperative Period After assessing patients' eligibility on the day of the surgery and written informed consent is obtained, subjects will be randomized into two groups: placebo group (group I) and gabapentin group (group II).
Pain level will be assessed and recorded at baseline using the verbal NPRS. A single dose of study medication will be administered within 2 hours before scheduled surgery time. Patients randomized to group I will receive matched oral placebo whereas patients randomized to group II will receive 900 mg of oral gabapentin. Once provided by pharmacy, the study medication will be administered by a blinded nurse in the preoperative area.
Intraoperative Period General anesthesia with desflurane and fentanyl will be provided in all patients. Other anesthetic procedures including intraoperative monitoring, muscle relaxation, endotracheal intubation, mechanical ventilation, fluid management, and the use of intravenous dexamethasone will be carried out in accordance with standard procedures. Ondansetron (4 mg) will be used as PONV prophylaxis in all patients 30 minutes before the end of the surgery. Moreover, an orogastric tube (OGT) will be used for stomach emptying at the end of the surgery and before the emergence of anesthesia.
Postoperative period Closure time will be recorded as T0. The time elapsed from PACU arrival until the first opioid dose (either oral or IV) will be recorded. Once in PACU, patients will receive IV fentanyl as pain rescue medication if required and PACU length of stay will be also recorded. After patients are considered stable based on clinician assessment and willingness to start oral intake, a treatment with oral acetaminophen 650 mg scheduled every 6 hours and oral oxycodone (5-10 mg) as needed (PRN) will be initiated for all patients.
Anesthesiologists and researchers evaluating postoperative outcomes will be blinded. The verbal NPRS will be used to assess postoperative pain level at PACU arrival, and every 30 minutes until hospital discharge. After discharge, pain levels will be recorded by patients in their diary at T6, T12, T24 (6, 12, and 24 hours after T0 respectively), and before requiring breakthrough medication (oxycodone) until postoperative day (POD) 7.
Follow-up phase Patients will be discharged home as per standard of care with oral acetaminophen 650 mg scheduled every 6 hours and a prescription for oral oxycodone 5-10 mg every 4 hours as needed (PRN). At discharge, the patient will be instructed to record his oral opioid consumption (oxycodone) and NPRS scores before each oxycodone dose until POD 7 (see attached diary).
A follow-up visit will be matched with the standard postsurgical visit at POD 7 in order to collect the diary, and count the remaining pills from the oxycodone bottle. Adverse events (AEs) including nausea and vomiting will be assessed and documented during the whole study participation.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Gabapentin, Placebos
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurotin
Gabapentin has been commonly used as an adjuvant in the treatment of neuropathic pain.
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | The primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty. Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | The primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Gabapentin vs Placebo in Postoperative Opioid Consumption
To assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty.
Measured: 72 hours
Secondary outcomes (8)
Pain Assessment
To assess postoperative pain based on verbal Numeric Pain Rating Scale (NPRS), zero being no pain and ten being the worst possible pain, in the post-anesthesia care unit (PACU) and upon discharge.
Measured: 7 days
IV Opioids in PACU
To compare intravenous opioid consumption during PACU stay
Measured: 7 days
Time to rescue medication
To determine the time elapsed from PACU arrival until the first dose of postoperative pain rescue medication requested by the patient
Measured: 7 days
Opioids within 7 days
To compare opioid consumption and NPRS within the first 7 days after the surgery
Measured: 7 days
Length of stay (minutes) in recovery from end of surgery until discharge.
To assess the post-anesthesia care unit length of stay (minutes) from end of the surgery until the end of recovery phase II
Measured: 7 days
Nausea
To compare the incidence of postoperative nausea and vomiting during PACU stay
Measured: 7 days
Side Effects
To assess the incidence of gabapentin-related side effects
Measured: 7 days
Respiratory Distress
To assess the incidence of respiratory distress during post-anesthesia care unit stay, defined as oxygen saturation ≤ 92%
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start30 Jan 2018
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Adult patients scheduled to undergo rhinoplasty at the Ohio State University Wexner Medical Center
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Kim, Ohio State University
- Investigators
- Leslie Kim, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498261
- Sponsor's protocol ID
- 2017H0466
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2018
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ishii LE, Tollefson TT, Basura GJ, Rosenfeld RM, Abramson PJ, Chaiet SR, Davis KS, Doghramji K, Farrior EH, Finestone SA, Ishman SL, Murphy RX Jr, Park JG, Setzen M, Strike DJ, Walsh SA, Warner JP, Nnacheta LC. Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty Executive Summary. Otolaryngol Head Neck Surg. 2017 Feb;156(2):205-219. doi: 10.1177/0194599816683156.
PubMed 28145848Demirhan A, Tekelioglu UY, Akkaya A, Bilgi M, Apuhan T, Karabekmez FE, Bayir H, Kurt AD, Kocoglu H. Effect of pregabalin and dexamethasone addition to multimodal analgesia on postoperative analgesia following rhinoplasty surgery. Aesthetic Plast Surg. 2013 Dec;37(6):1100-6. doi: 10.1007/s00266-013-0207-0. Epub 2013 Sep 21.
PubMed 24057811Sari E, Simsek G. Comparison of the Effects of Total Nasal Block and Central Facial Block on Acute Postoperative Pain, Edema, and Ecchymosis After Septorhinoplasty. Aesthetic Plast Surg. 2015 Dec;39(6):877-80. doi: 10.1007/s00266-015-0565-x. Epub 2015 Sep 22.
PubMed 26395094Wittekindt D, Wittekindt C, Schneider G, Meissner W, Guntinas-Lichius O. Postoperative pain assessment after septorhinoplasty. Eur Arch Otorhinolaryngol. 2012 Jun;269(6):1613-21. doi: 10.1007/s00405-011-1854-x. Epub 2011 Dec 1.
PubMed 22130915Argoff CE. Recent management advances in acute postoperative pain. Pain Pract. 2014 Jun;14(5):477-87. doi: 10.1111/papr.12108. Epub 2013 Aug 15.
PubMed 23945010Han B, Compton WM, Blanco C, Jones CM. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults. Ann Intern Med. 2018 Mar 6;168(5):383-384. doi: 10.7326/L17-0700. No abstract available.
PubMed 29507965Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26.
PubMed 27459955Turan 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.
PubMed 15271709Kazak Z, Meltem Mortimer N, Sekerci S. Single dose of preoperative analgesia with gabapentin (600 mg) is safe and effective in monitored anesthesia care for nasal surgery. Eur Arch Otorhinolaryngol. 2010 May;267(5):731-6. doi: 10.1007/s00405-009-1175-5. Epub 2009 Dec 10.
PubMed 20012076Helander EM, Billeaud CB, Kline RJ, Emelife PI, Harmon CM, Prabhakar A, Urman RD, Kaye AD. Multimodal Approaches to Analgesia in Enhanced Recovery After Surgery Pathways. Int Anesthesiol Clin. 2017 Fall;55(4):51-69. doi: 10.1097/AIA.0000000000000165. No abstract available.
PubMed 28901981Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.
PubMed 23681498
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
- ClinicalTrials.gov ID
- NCT03498261
- Acronym / sponsor ID
- 2017H0466
- Conditions
- Pain, Postoperative, Opioid Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Apr 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.
Adding a single preoperative dose of gabapentin to the standard pain regimen will reduce postoperative opioid consumption within the first 72 hours in patients undergoing rhinoplasty.
Detailed description
Study Design A prospective randomized double blind study will be conducted to assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty at The Ohio State University Wexner Medical Center.
Preoperative Period After assessing patients' eligibility on the day of the surgery and written informed consent is obtained, subjects will be randomized into two groups: placebo group (group I) and gabapentin group (group II).
Pain level will be assessed and recorded at baseline using the verbal NPRS. A single dose of study medication will be administered within 2 hours before scheduled surgery time. Patients randomized to group I will receive matched oral placebo whereas patients randomized to group II will receive 900 mg of oral gabapentin. Once provided by pharmacy, the study medication will be administered by a blinded nurse in the preoperative area.
Intraoperative Period General anesthesia with desflurane and fentanyl will be provided in all patients. Other anesthetic procedures including intraoperative monitoring, muscle relaxation, endotracheal intubation, mechanical ventilation, fluid management, and the use of intravenous dexamethasone will be carried out in accordance with standard procedures. Ondansetron (4 mg) will be used as PONV prophylaxis in all patients 30 minutes before the end of the surgery. Moreover, an orogastric tube (OGT) will be used for stomach emptying at the end of the surgery and before the emergence of anesthesia.
Postoperative period Closure time will be recorded as T0. The time elapsed from PACU arrival until the first opioid dose (either oral or IV) will be recorded. Once in PACU, patients will receive IV fentanyl as pain rescue medication if required and PACU length of stay will be also recorded. After patients are considered stable based on clinician assessment and willingness to start oral intake, a treatment with oral acetaminophen 650 mg scheduled every 6 hours and oral oxycodone (5-10 mg) as needed (PRN) will be initiated for all patients.
Anesthesiologists and researchers evaluating postoperative outcomes will be blinded. The verbal NPRS will be used to assess postoperative pain level at PACU arrival, and every 30 minutes until hospital discharge. After discharge, pain levels will be recorded by patients in their diary at T6, T12, T24 (6, 12, and 24 hours after T0 respectively), and before requiring breakthrough medication (oxycodone) until postoperative day (POD) 7.
Follow-up phase Patients will be discharged home as per standard of care with oral acetaminophen 650 mg scheduled every 6 hours and a prescription for oral oxycodone 5-10 mg every 4 hours as needed (PRN). At discharge, the patient will be instructed to record his oral opioid consumption (oxycodone) and NPRS scores before each oxycodone dose until POD 7 (see attached diary).
A follow-up visit will be matched with the standard postsurgical visit at POD 7 in order to collect the diary, and count the remaining pills from the oxycodone bottle. Adverse events (AEs) including nausea and vomiting will be assessed and documented during the whole study participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Adult patients scheduled to undergo rhinoplasty at the Ohio State University Wexner Medical Center
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinThe primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty. |
| Placebo | Placebo comparator | Drug: PlacebosThe primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients males and females ≥ 18 years old
- Patients providing a written informed consent in English language
- Patients scheduled to undergo rhinoplasty under general endotracheal anesthesia
Key exclusion criteria (10 listed)
- Patients with known allergies to medications described in this study: acetaminophen, gabapentin, and opioids (morphine, fentanyl, hydromorphone, oxycodone)
- Patients with chronic use of opioids due to any medical/surgical condition or those receiving any opioid medication within the 48 hours before surgery
- Use of gabapentin and/or pregabalin within the last 14 days prior to surgery
- Use of acetaminophen within the last 7 days prior to surgery
- Hepatic disease as documented in patient past medical history
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 |
|---|---|---|
| GabapentinAlso: NeurotinGabapentin has been commonly used as an adjuvant in the treatment of neuropathic pain. | Drug | Gabapentin |
| PlacebosPlacebo | Drug | Placebo |
Primary outcome
Effects of Gabapentin vs Placebo in Postoperative Opioid Consumption
Time frame: 72 hours
To assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty.
8 secondary outcomes
Pain Assessment
Time frame: 7 days
IV Opioids in PACU
Time frame: 7 days
Time to rescue medication
Time frame: 7 days
Opioids within 7 days
Time frame: 7 days
Length of stay (minutes) in recovery from end of surgery until discharge.
Time frame: 7 days
Nausea
Time frame: 7 days
Side Effects
Time frame: 7 days
Respiratory Distress
Time frame: 7 days
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 25 Sep 2026.
- Background: PubMed 28145848Ishii LE, Tollefson TT, Basura GJ, Rosenfeld RM, Abramson PJ, Chaiet SR, Davis KS, Doghramji K, Farrior EH, Finestone SA, Ishman SL, Murphy RX Jr, Park JG, Setzen M, Strike DJ, Walsh SA, Warner JP, Nnacheta LC. Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty Executive Summary. Otolaryngol Head Neck Surg. 2017 Feb;156(2):205-219. doi: 10.1177/0194599816683156.
- Background: PubMed 24057811Demirhan A, Tekelioglu UY, Akkaya A, Bilgi M, Apuhan T, Karabekmez FE, Bayir H, Kurt AD, Kocoglu H. Effect of pregabalin and dexamethasone addition to multimodal analgesia on postoperative analgesia following rhinoplasty surgery. Aesthetic Plast Surg. 2013 Dec;37(6):1100-6. doi: 10.1007/s00266-013-0207-0. Epub 2013 Sep 21.
- Background: PubMed 26395094Sari E, Simsek G. Comparison of the Effects of Total Nasal Block and Central Facial Block on Acute Postoperative Pain, Edema, and Ecchymosis After Septorhinoplasty. Aesthetic Plast Surg. 2015 Dec;39(6):877-80. doi: 10.1007/s00266-015-0565-x. Epub 2015 Sep 22.
- Background: PubMed 22130915Wittekindt D, Wittekindt C, Schneider G, Meissner W, Guntinas-Lichius O. Postoperative pain assessment after septorhinoplasty. Eur Arch Otorhinolaryngol. 2012 Jun;269(6):1613-21. doi: 10.1007/s00405-011-1854-x. Epub 2011 Dec 1.
- Background: PubMed 23945010Argoff CE. Recent management advances in acute postoperative pain. Pain Pract. 2014 Jun;14(5):477-87. doi: 10.1111/papr.12108. Epub 2013 Aug 15.
- Background: PubMed 29507965Han B, Compton WM, Blanco C, Jones CM. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults. Ann Intern Med. 2018 Mar 6;168(5):383-384. doi: 10.7326/L17-0700. No abstract available.
- Background: PubMed 27459955Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26.
- Background: PubMed 15271709Turan 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.
- Background: PubMed 20012076Kazak Z, Meltem Mortimer N, Sekerci S. Single dose of preoperative analgesia with gabapentin (600 mg) is safe and effective in monitored anesthesia care for nasal surgery. Eur Arch Otorhinolaryngol. 2010 May;267(5):731-6. doi: 10.1007/s00405-009-1175-5. Epub 2009 Dec 10.
- Background: PubMed 28901981Helander EM, Billeaud CB, Kline RJ, Emelife PI, Harmon CM, Prabhakar A, Urman RD, Kaye AD. Multimodal Approaches to Analgesia in Enhanced Recovery After Surgery Pathways. Int Anesthesiol Clin. 2017 Fall;55(4):51-69. doi: 10.1097/AIA.0000000000000165. No abstract available.
- Background: PubMed 23681498Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.
- 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.
Leslie Kim, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gabapentin in people with Pain, Postoperative and Opioid Use, run by Ohio State University at 1 site in United States.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Effects of Gabapentin vs Placebo in Postoperative Opioid Consumption (time frame: 72 hours). 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 NCT03498261, which also lists 11 linked publications.
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 25 Sep 2026.