At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
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
Timeline
Interventions
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
Celecoxib 200mg PO q 12h x 7d post op
30mg IV once at end of hysterectomy procedure
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
1mg IV PRN q3h, post op, while inpatient
To be discharged home with: 12 tabs of 5mg PRN q4h