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Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy (TAP)

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP block
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Postoperative pain, TAP block, Hysterectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-80 years old
  • Female ASA physical status 1-3 scheduled for abdominal hysterectomy
  • Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

  • History of relevant drug allergy
  • Age less than 18 or greater than 80
  • Chronic opioid users who may have a tolerance to opioids
  • Psychiatric disturbance
  • Inability to understand the study protocol procedures
  • Patient refusal

Sites / Locations

  • UTSW Parkland Health Hospital System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Ketorolac 30 mg, IV + TAP block

TAP block

Ketorolac 30 mg

Arm Description

Ketorolac 30 mg, IV + Bilateral ultrasound-guided TAP blocks at the end of the surgery First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Intraoperative (at the end of surgery): Bilateral ultrasound-guided TAP block at the end of the surgery First 24-h Postoperative: IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Intraoperative (at the end of surgery): Ketorolac 30 mg, IV at the end of the surgery. First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h +IV-PCA morphine. 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Outcomes

Primary Outcome Measures

Morphine Consumption
Morphine consumption over the first 24 hours

Secondary Outcome Measures

Full Information

First Posted
June 28, 2010
Last Updated
January 31, 2018
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01153503
Brief Title
Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy
Acronym
TAP
Official Title
Ultrasound-guided Transversus Abdominis Plane Block After Abdominal Hysterectomy: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management in patients undergoing abdominal hysterectomy.
Detailed Description
Patients undergoing abdominal hysterectomy (n=75) at Parkland Hospital will be randomized into one of three groups to receive either ultrasound-guided bilateral TAP block with or without NSAIDs and acetaminophen (Groups 1 and 2) or the conventional analgesic regimen (Group 3) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique, will be standardized and similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively. The pre-anesthesia care unit personnel will identify patients during their preoperative clinic visit. There will be no incentive or payment to the patients. Patients in Group 1 and 2 will receive ultrasound-guided bilateral TAP block after surgery. In the first 24-h postoperative period, patients in Groups 1 and 3 will receive acetaminophen 650 mg every 6 h orally, ketorolac 30 mg every 6 h, and morphine via an intravenous patient controlled analgesia (IV-PCA) system to maintain adequate pain control. Patients in Group 2 will receive IV-PCA morphine for the first 24 hours in addition to the ultrasound-guided bilateral block. In the 24-48 h study period, all patients will receive oral ibuprofen 800 mg three times a day and a combination of hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets every 6h, prn. The postoperative analgesia will be documented using the visual analog score (0=no pain,10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation. Primary endpoint will be in about 24 hours after surgery morphine consumption. The secondary endpoints will include the VAS pain score at 6, 12, 24 and 48 hours after surgery and side effects associated with morphine use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Postoperative pain, TAP block, Hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac 30 mg, IV + TAP block
Arm Type
Active Comparator
Arm Description
Ketorolac 30 mg, IV + Bilateral ultrasound-guided TAP blocks at the end of the surgery First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
Intraoperative (at the end of surgery): Bilateral ultrasound-guided TAP block at the end of the surgery First 24-h Postoperative: IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Arm Title
Ketorolac 30 mg
Arm Type
No Intervention
Arm Description
Intraoperative (at the end of surgery): Ketorolac 30 mg, IV at the end of the surgery. First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h +IV-PCA morphine. 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
Group Intraoperative (at the end of surgery): Ketorolac 30 mg, IV + TAP block; TAP block First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Primary Outcome Measure Information:
Title
Morphine Consumption
Description
Morphine consumption over the first 24 hours
Time Frame
24 hours post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-80 years old Female ASA physical status 1-3 scheduled for abdominal hysterectomy Able to participate personally or by legal representative in informed consent in English or Spanish Exclusion Criteria: History of relevant drug allergy Age less than 18 or greater than 80 Chronic opioid users who may have a tolerance to opioids Psychiatric disturbance Inability to understand the study protocol procedures Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Gasanova, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTSW Parkland Health Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23291970
Citation
Gasanova I, Grant E, Way M, Rosero EB, Joshi GP. Ultrasound-guided transversus abdominal plane block with multimodal analgesia for pain management after total abdominal hysterectomy. Arch Gynecol Obstet. 2013 Jul;288(1):105-11. doi: 10.1007/s00404-012-2698-3. Epub 2013 Jan 6.
Results Reference
derived

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Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy

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