TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

PHASE4CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

June 30, 2017

Conditions
Acute Pain
Interventions
DRUG

Liposomal Bupivacaine

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.

DRUG

Bupivacaine

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

DEVICE

Ultrasound

An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane

DRUG

Epinephrine

TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.

DRUG

acetaminophen

all individuals will receive scheduled acetaminophen (1 gram every 6 hours),

DRUG

ibuprofen

all individuals will receive scheduled ibuprofen (800 mg every 8 hours)

DRUG

Oxycodone

all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Trial Locations (1)

55455

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT02519023 - TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy | Biotech Hunter | Biotech Hunter