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

Summary

Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

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.

Sponsors & Collaborators

• University of Minnesota

  lead OTHER

Principal Investigators

• Melissa Geller, MD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-05-31

Completion

2017-06-30

Countries

• United States

Study Locations