Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Ying Liu
Study ID
NCT04130464
Phase
PHASE4
Status
Recruiting
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Conditions

  • Gynecologic Surgical Procedures
  • Hysterectomy
  • Narcotic Use
  • Pain, Postoperative

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ropivacaine Infusion from ON-Q Pump — DRUG
    Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
  • Ropivacaine + Ketorolac Infusion from ON-Q Pump — DRUG
    Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
  • Normal Saline Infusion from ON-Q Pump — DRUG
    Infusion of 0.9% normal saline at 8 mL/hour for 72 hours

Study Details

The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.

Key Dates

Start date
Sep 30, 2019
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ropivacaine
    Subjects will receive a continuous intraperitoneal infusion of ropivacaine
  • Experimental: Ropivacaine + Ketorolac
    Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac
  • Placebo Comparator: Normal Saline
    Subjects will receive a continuous intraperitoneal infusion of normal saline

Primary Outcome Measure

Pain Level 1 Hour Postoperative [ Time Frame: 1 hour postoperative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
James Robinson, MD
[email protected]
202-877-0526
James Robinson, MD (PRINCIPAL_INVESTIGATOR)
The GW Medical Faculty AssociatesWashington D.C.District of Columbia20037
Jennifer Keller, MD
[email protected]
202 741 2524
Jennifer Keller, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Washington Hospital Center· Washington D.C., DCThe GW Medical Faculty Associates· Washington D.C., DC

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