NCT01153503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 22, 2014

Completed
Last Updated

March 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

June 28, 2010

Results QC Date

March 18, 2014

Last Update Submit

January 31, 2018

Conditions

Post Operative Pain

Keywords

Postoperative pain, TAP block, Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Morphine Consumption

    Morphine consumption over the first 24 hours

    24 hours post surgery

Study Arms (3)

Ketorolac 30 mg, IV + TAP block

ACTIVE COMPARATOR

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

Procedure: TAP block

TAP block

ACTIVE COMPARATOR

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

Procedure: TAP block

Ketorolac 30 mg

NO INTERVENTION

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

Interventions

TAP blockPROCEDURE

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

Ketorolac 30 mg, IV + TAP blockTAP block

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTSW Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 23291970DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Irina Gasanova, MD, PhD
Organization
University of Texas Southwestern Medical Center
Irina.Gasanova@UTSouthwestern.edu
214-590-0064

Study Officials

  • Irina Gasanova, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC PROFESSOR

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 30, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 1, 2018

Results First Posted

April 22, 2014

Record last verified: 2018-01

Locations

US(1)