A Phase 4 interventional study of Gabapentin and Acetaminophen in Pain, Postoperative, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Christiana Care Health Services · Phase 4, Interventional, and Prevention
The purpose of the investigators' study is to assess the efficacy of a single dose of preoperative gabapentin within an enhanced recovery after surgery protocol in acute postoperative pain reduction for women undergoing a minimally invasive hysterectomy. Participants who consent to participate will be randomized to either a control group without gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery. The investigators will collect data on postoperative narcotic use, subjective pain as rated by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.
Multimodal postoperative analgesia after a hysterectomy has been mainly based on a combination of nonsteroidal anti-inflammatory drugs and opioids. However, adverse effects including nausea, vomiting, sedation, and pruritus may limit use of opioids. As the side effects are dose related, minimizing opioid exposure may significantly reduce these risks. Thus, there has been an interest in evaluating preemptive as well as post-operative administration of non-opioids. Additional regimens have been suggested to minimize opioid use and its associated adverse effects including injection of local anesthetics, epidural analgesia, and anticonvulsants, such as gabapentin or pregabalin.
Gabapentin, a widely used anticonvulsant used for treatment of neuropathic pain, has recently been suggested to improve postoperative analgesia and reduce opioid requirements. Gabapentin is thought to modulate calcium channels on the presynaptic nociceptive neurons, which in turn modulate or inhibit the release of excitatory neurotransmitters from activated nociceptors. In addition to inhibiting pain transmission, gabapentin may exert an analgesic effect by activating descending inhibitory noradrenergic pathways.
Many studies have demonstrated the safety and efficacy of gabapentin for perioperative use in a variety of procedures across disciplines including thoracotomy, laparoscopic cholecystectomy, tonsillectomy, major orthopedic surgery, cesarean sections, and abdominal hysterectomy. Several randomized trials have evaluated the effects of gabapentin administered preoperatively only as well as given pre- and postoperatively for hysterectomy. In a systematic review of 14 studies conducted between 2004 and 2013, with samples ranging from 40 to 200, investigators identified 8 trials in which gabapentin was administered only preoperatively to reduce pain associated with abdominal hysterectomy surgery. Analysis of those data clearly demonstrates that preemptive gabapentin reduced the postoperative visual analog scale (VAS) pain score by approximately 50% and postoperative use of morphine by approximately 37%. The incidence of pruritus and dry mouth in those receiving preemptive gabapentin appeared similar to those receiving placebo, however there was a higher rate of reported dizziness (not statistically significant) associated with gabapentin. In contrast, multiple postoperative doses of gabapentin in addition to the preoperative dose was found to have no significant effect on VAS scores at 24 hours, thus favoring a single preoperative dose.
Although initial results have been encouraging, uptake of gabapentin in routine clinical use remains limited due to mixed results and variability between gabapentin protocols, including dosing and duration. Christiana Care Health System (CCHS) plans to implement the Enhanced Recovery After Surgery (ERAS) protocol which administers preoperative medications to reduce postoperative pain, including acetaminophen, celecoxib, dexamethasone, and gabapentin. Therefore the aim of this study is to assess the efficacy of a single dose of preoperative gabapentin protocol to reduce acute postoperative pain in women undergoing a minimally invasive hysterectomy.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 137 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include: Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Drug: Gabapentin · Drug: Acetaminophen · Drug: Celecoxib
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include: Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Drug: Acetaminophen · Drug: Celecoxib
Narcotic Use at 24 Hours Postop
Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
Time frame: 24 hours
Subjective Pain at 24 Hours Postoperative
Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain.
Time frame: 24 hours
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Will assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
Time frame: 24 hours
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
Time frame: 2 weeks
Narcotic Use at 2 Weeks Postop
Assessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
Time frame: 2 weeks
Subjective Pain at 2 Weeks Postop
Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10. The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible
Time frame: 2 weeks
Patient were recruited from June 2016 to July 2017 via phone or in the office setting. Potential subjects were informed of the study by investigators and if they desired to participate, they either signed consents forms in the office or on the day of surgery.
| Milestone | Gabapentin | Control |
|---|---|---|
| Started | 70 | 67 |
| Completed | 68 | 61 |
| Not completed | 2 | 6 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Excluded from analysis per protocol | 1 | 2 |
| Milestone | Gabapentin | Control |
|---|---|---|
| Started | 68 | 61 |
| Completed | 58 | 51 |
| Not completed | 10 | 10 |
| Withdrew: Lost to follow-up | 10 | 10 |
Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
| morphine milligram equivalents | Gabapentin | Control |
|---|---|---|
| Narcotic Use at 24 Hours Postop | 158.8 ± 109.6 | 175.0 ± 162.5 |
Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain.
| score on a scale | Gabapentin | Control |
|---|---|---|
| Subjective Pain at 24 Hours Postoperative | 3.4 ± 2.5 | 3.4 ± 2.5 |
Will assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
| Participants | Gabapentin | Control |
|---|---|---|
| Dizziness | 17 | 8 |
| Blurred Vision | 7 | 4 |
| Somnolence | 20 | 23 |
| Difficulty walking | 13 | 11 |
| Tremulousness | 11 | 6 |
| Nausea | 24 | 25 |
| Vomiting | 9 | 15 |
Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
| Participants | Gabapentin | Control |
|---|---|---|
| Dizziness | 12 | 8 |
| Blurred vision | 4 | 3 |
| Somnolence | 18 | 21 |
| Difficulty walking | 5 | 5 |
| Tremulousness | 4 | 2 |
| Nausea | 12 | 7 |
| Vomiting | 0 | 1 |
Assessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
| morphine milligram equivalents | Gabapentin | Control |
|---|---|---|
| Narcotic Use at 2 Weeks Postop | 167.2 ± 79.3 | 187.3 ± 185.5 |
Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10. The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible
| score on a scale | Gabapentin | Control |
|---|---|---|
| Subjective Pain at 2 Weeks Postop | 1.3 ± 2.0 | 1.4 ± 1.8 |
Collected over Adverse event data collected from time of enrollment to 2 weeks postoperative.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Control | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Age, Continuous(years) | Gabapentin | Control | Total |
|---|---|---|---|
| Mean | 49.7 ± 12.56 | 52.3 ± 11.6 | 51.2 ± 12.17 |
| Sex: Female, Male(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Female | 68 | 61 | 129 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Caucasian | 43 | 46 | 89 |
| African American/African | 25 | 15 | 40 |
| Other | 1 | 4 | 5 |
| Region of Enrollment(participants) | Gabapentin | Control | Total |
|---|---|---|---|
| United States | 68 | 61 | 129 |
| BMI(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| < 30 kg/m^2 | 36 | 28 | 64 |
| >/= 30 kg/m^2 | 32 | 33 | 65 |
| Narcotic Use within week prior to surgery(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Count of participants | 11 | 18 | 29 |
| History chronic pain(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Count of participants | 26 | 24 | 50 |
| Prior abdominal surgery(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Count of participants | 43 | 44 | 87 |
9 further baseline measures are reported on the registry.
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Christiana Care Health Services