Phase 4
Completed N=77
Gabapentin Regimens and Their Effects on Opioid Consumption
Source: ClinicalTrials.gov NCT03334903 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Opioid Consumption — 287.0; 281.1 morphine equivalents
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine the best strategy of administering gabapentin in connection with our current approach to perioperative pain management. We aim to evaluate two different adjunct gabapentin regimens given in the perioperative period, and to identify which manages patient pain more effectively and safely. In this evaluation, we will identify the quantity of patients' opioid consumption, the quality of their pain management, and the frequency and severity of any side effects they might experience.
Patients who are undergoing total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group using computer-generated randomization. Patients in group 1 (the control group) will receive the standard of care as pertains to gabapentin. This consists of a single 600 mg dose of gabapentin administered to the patient approximately one to two hours before surgery, then a dose of 600 mg each morning during postoperative admission. Patients in Group 2 will receive 600 mg preoperatively, plus an additional postoperative gabapentin regimen: they will take 300 mg of gabapentin every 8 hours for 1 week, then a single nightly dose of 300 mg for another month.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption |
287.0; 281.1 | — |
| SECONDARY Days Taking Opioids |
14.8; 18.7 | — |
| SECONDARY VAS Score 1: "How Much Pain do You Feel in Your Operative Site When Resting?" |
2.26; 2.46 | — |
| SECONDARY VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?" |
3.84; 3.54 | — |
| SECONDARY VAS Score 3: "How Well Are You Sleeping?" |
5.73; 6.38 | — |
| SECONDARY VAS Score 4: "How Bad is Your Nausea?" |
0.36; 0.17 | — |
| SECONDARY VAS Score 5: "How Satisfied Are You With Your Pain Management?" |
7.83; 8.48 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Receiving surgery for total knee replacement (TKR)
- Opioid naïve
- Agrees to use tracking diary to monitor opioid consumption
Exclusion Criteria
- Over 75 years of age on the date of surgery
- If female, pregnant
- Has received investigational articles < 30 days prior to enrollment or is currently receiving investigational products or devices
- Chronic pain syndrome
- Taking chronic narcotics and/or taking more than 10 mg of codeine per day, any amount of Hydrocodone, over 200 mg of tramadol per day, or any other narcotics prescribed for moderate or severe pain
- Involved in pain clinics for chronic pain, or pain that is not related to the surgical site
- On long-term gabapentin regimen
- Taking Lyrica or Gralise
- Known history of depression or has been treated for depression with medication
- Has entertained suicidal thoughts and behaviors
Data sourced from ClinicalTrials.gov (NCT03334903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.