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Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites for Postoperative Pain (RA-TLH Trial)

Phase 3
Waitlist Available
Led By Sarah Andres, D.O.
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-24 hours after surgery
Awards & highlights

RA-TLH Trial Summary

This trial is testing a new pain medication regimen for people who have had a hysterectomy, to see if it will reduce post-operative opioid use.

RA-TLH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-24 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-24 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
Total Opioid Pain Medications Required Through 3-24h Post op in MME
Secondary outcome measures
Estimated Blood Loss
Length of Stay in Hours
Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
+2 more

RA-TLH Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective cohortExperimental Treatment8 Interventions
Pre-Op: Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op) Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Intra-Op: Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg At end of procedure during closure of fascia, give 30mg ketorolac IV x 1 Post-Op: Gabapentin 300mg PO BID for 7 days Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN Celecoxib 200mg PO q 12h x 7d Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
Group II: Historical ControlActive Control1 Intervention
Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Paracervical block with ropivacaine
2020
Completed Phase 3
~70
Gabapentin
2013
Completed Phase 4
~1550
Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
2020
Completed Phase 3
~70
Hydromorphone
2005
Completed Phase 4
~4340
Celecoxib
2019
Completed Phase 4
~1740
Ketorolac
2014
Completed Phase 4
~1760
Oxycodone
2014
Completed Phase 4
~2210

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,420 Total Patients Enrolled
Sarah Andres, D.O.3.511 ReviewsPrincipal Investigator - University at Buffalo
State University of New York at Buffalo
5Patient Review
Dr. White is an excellent doctor who has been supportive throughout my breast cancer diagnosis. She sincere, understanding, and never condescending. I highly recommend her!

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JAMA Network OpenJournal
Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery
Mark, Jaron, Deanna M. Argentieri, Camille A. Gutierrez, Kayla Morrell, Kevin Eng, Alan D. Hutson, Paul Mayor, et al.. 2018. “Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2018.5452.
clinicaltrials.govStudy
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Sarah Andres, D.O. 2020. "Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04429022.
~15 spots leftby Apr 2025
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