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
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| ClinicalTrials.gov Identifier: NCT03498261 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2018
Last Update Posted : September 24, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative Opioid Use | Drug: Gabapentin Drug: Placebos | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Adult patients scheduled to undergo rhinoplasty at the Ohio State University Wexner Medical Center |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Once the randomization group has been defined, the pharmacist will prepare both medications and will place them inside a bag for further handling. Medications will be identified following institutional standard of procedures. |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | January 30, 2018 |
| Estimated Primary Completion Date : | December 30, 2022 |
| Estimated Study Completion Date : | December 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Gabapentin
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.
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Drug: Gabapentin
Gabapentin has been commonly used as an adjuvant in the treatment of neuropathic pain.
Other Name: Neurotin |
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Placebo Comparator: Placebo
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.
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Drug: Placebos
Placebo |
- 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.
- Pain Assessment [ Time Frame: 7 days ]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.
- IV Opioids in PACU [ Time Frame: 7 days ]To compare intravenous opioid consumption during PACU stay
- Time to rescue medication [ Time Frame: 7 days ]To determine the time elapsed from PACU arrival until the first dose of postoperative pain rescue medication requested by the patient
- Opioids within 7 days [ Time Frame: 7 days ]To compare opioid consumption and NPRS within the first 7 days after the surgery
- Length of stay (minutes) in recovery from end of surgery until discharge. [ Time Frame: 7 days ]To assess the post-anesthesia care unit length of stay (minutes) from end of the surgery until the end of recovery phase II
- Nausea [ Time Frame: 7 days ]To compare the incidence of postoperative nausea and vomiting during PACU stay
- Side Effects [ Time Frame: 7 days ]To assess the incidence of gabapentin-related side effects
- Respiratory Distress [ Time Frame: 7 days ]To assess the incidence of respiratory distress during post-anesthesia care unit stay, defined as oxygen saturation ≤ 92%
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498261
| Contact: Juan Fiorda, MD | 614-293-3559 | juan.fiorda@osumc.edu | |
| Contact: Alberto Uribe, MD | 614-293-3559 | alberto.uribe@osumc.edu |
| United States, Ohio | |
| The Ohio State University Wexner Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Alberto Uribe, MD 614-293-3559 Alberto.Uribe@osumc.edu | |
| Principal Investigator: Leslie Kim, MD | |
| Principal Investigator: | Leslie Kim, MD | Ohio State University |
| Responsible Party: | Leslie Kim, Assistant Professor - Clinical, Ohio State University |
| ClinicalTrials.gov Identifier: | NCT03498261 |
| Other Study ID Numbers: |
2017H0466 |
| First Posted: | April 13, 2018 Key Record Dates |
| Last Update Posted: | September 24, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |