A Phase 4 interventional study of Gabapentin and Placebo in Postoperative Pain, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Milton S. Hershey Medical Center · Phase 4, Interventional, and Treatment
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 112 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
Drug: Gabapentin
Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Other: Placebo
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
Also known as: Neurontin, 78309289
Patient will receive placebo tab less than 1 hour before surgery
NRS (Numerical Rating Scale)
The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.
Time frame: 2-8 hours
VAS (Visual Analog Scale)
The VAS is scored using a horizontal line 100mm in length. The scale is anchored by "no pain" (score of 0) and "worst pain" (score of 100).
Time frame: 2 -6 hours
Total Morphine Consumption
Time frame: 12 hours post-operatively
A total of 125 patients consented to the study, but 13 did not undergo surgery or rescheduled.
| Milestone | Gabapentin | Placebo |
|---|---|---|
| Started | 55 | 54 |
| Completed | 55 | 54 |
| Not completed | 0 | 0 |
The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Hour 2 | 3.5 (2.6 to 4.5) | 3.4 (2.5 to 4.4) |
| Hour 4 | 5.4 (4.3 to 6.5) | 5.5 (4.3 to 6.7) |
| Hour 6 | 5.3 (4.2 to 6.5) | 5.8 (4.4 to 7.1) |
| Hour 8 | 5.7 (4.3 to 7.2) | 5.1 (3.4 to 6.8) |
The VAS is scored using a horizontal line 100mm in length. The scale is anchored by "no pain" (score of 0) and "worst pain" (score of 100).
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Hour 2 | 37.8 (28.9 to 46.6) | 33.9 (25.3 to 42.6) |
| Hour 6 | 38.7 (28.6 to 48.7) | 36.9 (26.9 to 46.9) |
| mg | Gabapentin | Placebo |
|---|---|---|
| Total Morphine Consumption | 14.3 ± 12.6 | 14.7 ± 12.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Placebo | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Age, Continuous(years) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Mean | 40.4 ± 9.8 | 39.5 ± 9.4 | 39.9 ± 9.5 |
| Sex: Female, Male(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Female | 55 | 54 | 109 |
| Male | 0 | 0 | 0 |
| BMI(kg/m2) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Mean | 29.5 ± 7.2 | 30.0 ± 7.7 | 29.8 ± 7.4 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center