Phase 4
Completed N=137
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
Pain, Postoperative
Source: ClinicalTrials.gov NCT02703259 ↗
Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Narcotic Use at 24 Hours Postop — 158.8; 175.0 morphine milligram equivalents
◆ Published Evidence
Emerging
11citations · ~2 / year
Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial.
Summary
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.
Linked Publications
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Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Use at 24 Hours Postop |
158.8; 175.0 | — |
| PRIMARY Subjective Pain at 24 Hours Postoperative |
3.4; 3.4 | — |
| SECONDARY Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively |
17; 8; 7; 4; 20; 23 | — |
| SECONDARY Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively |
12; 8; 4; 3; 18; 21 | — |
| SECONDARY Narcotic Use at 2 Weeks Postop |
167.2; 187.3 | — |
| SECONDARY Subjective Pain at 2 Weeks Postop |
1.3; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- undergoing a minimally invasive hysterectomy with surgeons operating within the Christiana Care Health System at the Newark location only.
- at least 18 years of age
- able to swallow tablets or capsules
Exclusion Criteria
- liver failure
- renal failure
- prior gastric bypass
- gastroparesis
- recent or current regular gabapentin use
- hypersensitivity to gabapentin, acetominophen, or celecoxib
- procedure is converted to laparotomy for any indication. (Mini-laparotomy for specimen removal alone will not be excluded.)
Data sourced from ClinicalTrials.gov (NCT02703259) and the linked publication. 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.