CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
Gabapentin +7 moredrug
Likely dose
Gabapentin 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04429022
NCT04429022Phase 3Completed

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

State University of New York at Buffalo·interventional·Posted Jun 11, 2020·Updated Aug 1, 2023

In Brief

A Phase 3 clinical trial evaluating Gabapentin, Acetaminophen, and 6 other interventions for Pain, Postoperative. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartNov 24, 2020
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.1 years ago

Interventions

Gabapentindrug

600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op

Acetaminophendrug

Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op

Celecoxibdrug

Celecoxib 200mg PO q 12h x 7d post op

Ketorolacdrug

30mg IV once at end of hysterectomy procedure

Paracervical block with ropivacaineprocedure

0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL

Local anesthetic injection with ropivacaine at abdominal laparoscopic port sitesprocedure

0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total

Hydromorphonedrug

1mg IV PRN q3h, post op, while inpatient

Oxycodonedrug

To be discharged home with: 12 tabs of 5mg PRN q4h