Phase 3
N=68
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04429022 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) — 2.00; 5.32 morphine milligram equivalents (MME)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gabapentin (Drug); Acetaminophen (Drug); Celecoxib (Drug); Ketorolac (Drug); Paracervical block with ropivacaine (Procedure); Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites (Procedure); Hydromorphone (Drug); Oxycodone (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- State University of New York at Buffalo
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) |
2.00; 5.32 | — |
| PRIMARY Total Opioid Pain Medications Required Through 3-24h Post op in MME |
.20; 12.27 | — |
| SECONDARY Pain Scores |
3.82; 5.13 | — |
| SECONDARY Pain Scores |
3.82; 5.13 | — |
| SECONDARY Length of Stay in Hours |
12.05; 35.82 | — |
| SECONDARY Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period |
1; 3 | — |
| SECONDARY Operative Time |
128.80; 139.69 | — |
| SECONDARY Estimated Blood Loss |
63.50; 58.46 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
- Uterine weight ≤325 grams
Exclusion Criteria
- contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
- current opioid prescription
Data sourced from ClinicalTrials.gov (NCT04429022). 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.