PainNCT02840240
Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores
A study testing Gabapentin enacarbil in people with Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease your need for… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Gabapentin enacarbil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 23 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18-85 years of age.
- Scheduled for elective knee or hip arthroplasty with spinal anesthesia.
Who cannot join
- Creatinine >1.50 mg/dl.
- History of clinically important current depression or currently on any prescribed anti-depressant medication.
- Previously enrolled in any Xenoport trial.
- Use of gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise) within one month.
- Allergy to gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise).
- Women who are pregnant or breastfeeding.
- History of seizure disorder within the last one-year or taking medications for seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Determine the Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores in Patients Having Hip and Knee Arthroplasties With Spinal Anesthesia
Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease your need for narcotics and thus decrease the risk of side effects. The investigator hopes this study will determine if gabapentin enacarbil decreases opioid consumption and pain after surgery.
Patients having elective hip and knee surgery will be asked to participate in the study. Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo twice per day for 5 days.
One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil 600mg or placebo 600mg two hours before the surgical procedure. Six hours after the completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg. If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or placebo 600mg pills to take home along with instructions. However, if the patient remains hospitalized, on the first day after the surgery, the patient will have pain assessed in the morning using a numerical rating score. The patient's quality of recovery will be evaluated using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. The second and third day the patient is in the hospital, the patient will have pain assessed in the morning using a numerical rating score and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three months after surgery, the patient will receive a phone call to follow-up with possible pain or discomfort the patient may be feeling.
Read the detailed description
A randomized controlled trial to determine the effect of gabapentin enacarbil on opioid consumption and pain scores in patients having primary hip or knee replacement surgery with spinal anesthesia.
Screening visit
- Consent will be obtained
- Vital Signs
- Physical evaluation
- Medical History
- Laboratory values and medication checked via Epic
- Pain scores using numerical rating scores (NRS)
- Brief pain inventory (BPI)
- Randomization will be to standard management with GEn or to standard management with placebo. Patients will be given GEn 600 mg bid or placebo 600 mg bid for 1 preoperative day and will receive 600 mg GEn or placebo about 2 hours before surgery and then restarted on GEn or placebo 600 mg within 6 hours of surgery, and then 600 mg bid for three additional days. 2 days prior to surgery Phone call will be made to remind patients to take GEn 600 mg bid or placebo 600 mg bid 1 day prior to surgery
- vital signs
- GEn 600 mg bid or placebo 600 mg bid
- monitoring and recording of adverse events
Day of Surgery
- Medical History
- Laboratory values and medication checked via Epic
- Patients will be given GEn 600 mg or placebo single dose with sips of water 2 hours before surgery and then restarted within 6 hours of completion of surgery.
- Vital Signs
- Social history
- Demographic data to be obtained includes height (cm), weight (kg), age (yr), gender, (ASA) physical status, and self-declared ethnicity
- Individual risk for nausea and vomiting will be determined using the Apfel score.
- Monitoring and recording of adverse events
- Pain scores using numerical rating scores (NRS) during the PACU stay every 15 minutes for the first hour after surgery
POD 1
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning
- Myles QoR scale to formally evaluate quality of recovery
POD 2
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning
POD 3
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning 3 Months after surgery
- Phone call will be made to check for any adverse event and with the intention to assess chronic pain.
- Monitoring and recording of adverse events
- Data obtained from electronic medical records will include: operation time, surgery type, intraoperative opioid consumption, postoperative opioid consumption in PACU and in ward, breakthrough pain medication requirements, pain scores in PACU and ward, requirement of antiemetics for nausea and vomiting, requirement of antihistaminic medications, requirement of laxatives for constipation, ambulation time, flatus, ileus, bowel movements, length of stay and any side effects or complications. Preoperative and postoperative laboratory data including but not limited to renal function will also be collected from electronic medical records. Patient functionality will also be recorded including, bathing, toileting, walking and moving.
- Conditions
- Pain
- Being tested
- Gabapentin enacarbil, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin enacarbilDrug
Also called Xenoport
600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative
PlaceboDrug
600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin enacarbil | Experimental | Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Receives: Drug: Gabapentin enacarbil |
| Placebo | Placebo comparator | Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Weighted Average Pain Score in Numerical Rating Scores
Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient
Measured: Initial 72 hours after surgery or until discharge, whatever comes first.
Cumulative Postoperative Opioid Consumption
The total dose of opioid administered in the PACU and floor including the background analgesia (PCA) and boluses. All opioids will be converted into mg intravenous (IV) morphine equivalent to standardize opioid consumption .
Measured: Initial 72 hours after surgery or until discharge, whatever comes first.
Secondary outcomes (4)
Number of Participants With Persistent Pain 90-day After Surgery
Number of participants with persistent pain at 90 days after surgery
Measured: within 90 days after surgery
Postoperative Nausea and Vomiting (PONV) up to 72 Hours After Surgery
Postoperative nausea and vomiting (PONV) were recorded daily by nurses.
Measured: Initial 72 hours after surgery
Length of Hospital Stay in Hours
Duration of hospitalization (hours) was recorded from the end of surgery to discharge, and compared between groups on the medians.
Measured: From the end of surgery to discharge
Quality of Recovery (QoR-15) Score 72 Hours After Surgery
Quality of Recovery (QoR-15) survey was assessed by blinded investigators at 72 hours after surgery or shortly before hospital discharge, whichever came first. It is a patient-reported outcome ranging from 0 to 150. The higher scale indicates better recovery.
Measured: Initial 72 hours after surgery or shortly before hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion30 Nov 2018
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sessler, M.D., Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840240
- Sponsor's protocol ID
- 15-479
- Status last verified
- Jan 2024
- First submitted
- 23 May 2016
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Determine the Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores in Patients Having Hip and Knee Arthroplasties With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02840240
- Acronym / sponsor ID
- 15-479
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease your need for narcotics and thus decrease the risk of side effects. The investigator hopes this study will determine if gabapentin enacarbil decreases opioid consumption and pain after surgery.
Patients having elective hip and knee surgery will be asked to participate in the study. Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo twice per day for 5 days.
One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil 600mg or placebo 600mg two hours before the surgical procedure. Six hours after the completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg. If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or placebo 600mg pills to take home along with instructions. However, if the patient remains hospitalized, on the first day after the surgery, the patient will have pain assessed in the morning using a numerical rating score. The patient's quality of recovery will be evaluated using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. The second and third day the patient is in the hospital, the patient will have pain assessed in the morning using a numerical rating score and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three months after surgery, the patient will receive a phone call to follow-up with possible pain or discomfort the patient may be feeling.
Detailed description
A randomized controlled trial to determine the effect of gabapentin enacarbil on opioid consumption and pain scores in patients having primary hip or knee replacement surgery with spinal anesthesia.
Screening visit
- Consent will be obtained
- Vital Signs
- Physical evaluation
- Medical History
- Laboratory values and medication checked via Epic
- Pain scores using numerical rating scores (NRS)
- Brief pain inventory (BPI)
- Randomization will be to standard management with GEn or to standard management with placebo. Patients will be given GEn 600 mg bid or placebo 600 mg bid for 1 preoperative day and will receive 600 mg GEn or placebo about 2 hours before surgery and then restarted on GEn or placebo 600 mg within 6 hours of surgery, and then 600 mg bid for three additional days. 2 days prior to surgery Phone call will be made to remind patients to take GEn 600 mg bid or placebo 600 mg bid 1 day prior to surgery
- vital signs
- GEn 600 mg bid or placebo 600 mg bid
- monitoring and recording of adverse events
Day of Surgery
- Medical History
- Laboratory values and medication checked via Epic
- Patients will be given GEn 600 mg or placebo single dose with sips of water 2 hours before surgery and then restarted within 6 hours of completion of surgery.
- Vital Signs
- Social history
- Demographic data to be obtained includes height (cm), weight (kg), age (yr), gender, (ASA) physical status, and self-declared ethnicity
- Individual risk for nausea and vomiting will be determined using the Apfel score.
- Monitoring and recording of adverse events
- Pain scores using numerical rating scores (NRS) during the PACU stay every 15 minutes for the first hour after surgery
POD 1
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning
- Myles QoR scale to formally evaluate quality of recovery
POD 2
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning
POD 3
- GEn 600 mg bid or placebo 600 mg bid
- Vital Signs
- Monitoring and Recording of adverse events
- Pain scores using numerical rating scores (NRS) in the morning 3 Months after surgery
- Phone call will be made to check for any adverse event and with the intention to assess chronic pain.
- Monitoring and recording of adverse events
- Data obtained from electronic medical records will include: operation time, surgery type, intraoperative opioid consumption, postoperative opioid consumption in PACU and in ward, breakthrough pain medication requirements, pain scores in PACU and ward, requirement of antiemetics for nausea and vomiting, requirement of antihistaminic medications, requirement of laxatives for constipation, ambulation time, flatus, ileus, bowel movements, length of stay and any side effects or complications. Preoperative and postoperative laboratory data including but not limited to renal function will also be collected from electronic medical records. Patient functionality will also be recorded including, bathing, toileting, walking and moving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin enacarbil | Experimental | Drug: Gabapentin enacarbilPatients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPatients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women 18-85 years of age.
- Scheduled for elective knee or hip arthroplasty with spinal anesthesia.
Key exclusion criteria (7 listed)
- Creatinine >1.50 mg/dl.
- History of clinically important current depression or currently on any prescribed anti-depressant medication.
- Previously enrolled in any Xenoport trial.
- Use of gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise) within one month.
- Allergy to gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise).
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 |
|---|---|---|
| Gabapentin enacarbilAlso: Xenoport600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative | Drug | Gabapentin enacarbil |
| Placebo600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative | Drug | Placebo |
Primary outcome
Time Weighted Average Pain Score in Numerical Rating Scores
Time frame: Initial 72 hours after surgery or until discharge, whatever comes first.
Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient
Cumulative Postoperative Opioid Consumption
Time frame: Initial 72 hours after surgery or until discharge, whatever comes first.
The total dose of opioid administered in the PACU and floor including the background analgesia (PCA) and boluses. All opioids will be converted into mg intravenous (IV) morphine equivalent to standardize opioid consumption .
4 secondary outcomes
Number of Participants With Persistent Pain 90-day After Surgery
Time frame: within 90 days after surgery
Postoperative Nausea and Vomiting (PONV) up to 72 Hours After Surgery
Time frame: Initial 72 hours after surgery
Length of Hospital Stay in Hours
Time frame: From the end of surgery to discharge
Quality of Recovery (QoR-15) Score 72 Hours After Surgery
Time frame: Initial 72 hours after surgery or shortly before hospital discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Sessler, M.D. study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin enacarbil in people with Pain, run by The Cleveland Clinic 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 2 inclusion and 7 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 9 Jan 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Weighted Average Pain Score in Numerical Rating Scores (time frame: Initial 72 hours after surgery or until discharge, whatever comes first.). The study lists 2 primary outcomes in all. 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 9 Jan 2024.