Clinical trial NCT02506855: Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)
Official title: Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP): Modifying an Existing Technique for Ease of Administration and Increased Accuracy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study attempts to learn about the effectiveness of a modification to the Transversus Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the abdominal wall postoperatively using ultrasound guidance. The investigators want to see if regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread in the appropriate plane could reduce error and improve postoperative recovery.

Detailed description: This study is a prospective, randomized blinded study that investigates the efficacy of a transversus abdominis plane block under direct view. In this pilot study involving gynecologic patients undergoing open (abdominal wall incision either vertically or horizontally) hysterectomy or other related gynecologic surgery, the investigators will use ropivacaine versus saline for the placebo control group, which in both groups involves injection of agent directly into the appropriate fascial layers prior to abdominal wall closure. Efficacy is to be assessed via measurement of pain scores, nausea and vomiting, and opioid consumption in both participant groups. The number of dermatomes which are blocked in both participant groups during the first 24 hours following surgery will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age≥18 years old and not pregnant
* Must be able to provide informed consent - functional understanding of English
* Undergoes exploratory laparotomy with midline abdominal incision

Exclusion Criteria:

* History of substance abuse
* History of chronic pain syndrome
* Daily opioid use for more than 1 month
* Patients considered to have chorioamnionitis at the time of cesarean surgery as determined by the attending physician
* Prior abdominal surgery involving mesh or placement of an ostomy site as this may disrupt the plane in which the anesthetic may spread
* Allergy to local anesthetics
* History of cardiac arrhythmias or cardiac abnormalities
* History of seizure disorder
* Liver disease

Primary outcomes:
measure: Milligrams of Diludid Consumption During First 48 hours Following Surgery
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Level of Nerve (Dermatome) Block
timeFrame: 4hrs postoperative and on postoperative day 1
measure: Pain Scores at Rest and with Movement
timeFrame: 2, 4, 6, 12, 24, 36 and 48 hours postoperatively.
measure: Postoperative Nausea and Vomiting
timeFrame: 2, 4, 6, 12, 24, 36 and 48 hours postoperatively.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References: